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 .
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: A) “the device carrier is configured to releasably retain the sensor control device” (line 3) in claim 1; B) “The retaining element and interface are configured to store potential energy” in claim 2; C) “The second retaining element, when in the second configuration, is configured to engage” in claim 12; D) “The third retaining element, when in the second configuration, is configured to engage with” in claim 14;
The “device carrier” is a general place holder and a non-structural term that does not impose any specific structural limitation. The device carrier is modified by functional language, “configured to”, and is not further modified by sufficient structure, material or acts for performing the claim function. Accordingly, this limitation meets the 3-prong analysis, and therefore invokes 112(f). The specification discloses “the device carrier 3106 comprises the deflectable arm 3120” (0297), which functions as a structure and therefore provides a sufficient structure.
“The retaining element and interface are configured to store potential energy” in claim 2;
“The second retaining element, when in the second configuration, is configured to engage” in claim 12;
“The third retaining element, when in the second configuration, is configured to engage with” in claim 14;
“The retaining element”, “the second retaining element”, and “the third retaining element” are general place holder and non-structural term that does not impose any specific structural limitation. The retaining element, the second retaining element, and the third retaining element are modified by functional language, “configured to”, and are not further modified by sufficient structure, material or acts for performing the claim function. Accordingly, this limitation meets the 3-prong analysis, and therefore invokes 112(f). The specification discloses “The second retaining element may be similar to the (first) retaining element, and it may comprise similar features such as a protrusion and a recess. The second retaining element can be provided to resist distal movement after full sensor insertion.” (00267), and discloses “In the first embodiment, the third retaining element 3138 comprises a third recess 3144. The third recess 3144 is arranged adjacent to and proximally of the third projection 3142. This means that the third recess 3144 is bounded by the third projection 3142 at the distal edge. The third recess 3144 may be similar to the first recess 3126. The third recess 3144 is configured to receive the second protrusion 3140. The third recess 3144 has a complementary shape to the second protrusion 3140”. Therefore, the first retaining element, the second retaining element, and the third retaining element function as a structure and therefore provides a sufficient structure and similar structure (see Fig. 19B, 20B and 21B)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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. (FP 7.08.aia)
Claims 1, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Pace” (U.S Patent No 20130150691 A1).
Regarding claim 1, Pace teaches an insertion apparatus for inserting a sensor into skin of a subject (Paragraph 0011, 0078), comprising:
A sensor control device (sensor assembly 410, Fig. 10K-M) comprising a sensor (sensor 1102, Fig.11A), wherein the sensor is configured to penetrate the skin of the subject (Paragraph 0106: “All together, these drawings represent an example sequence of driving the sharp 1030 (supporting a sensor coupled to the on-body device 222) into the skin of a user,”);
A housing (casing 404) comprising a cover (cover 402) and a device carrier (platform 408/sensor assembly support 512) coupled to the cover, wherein the device carrier is configured to releasably retain the sensor control device (sensor assembly 410) (Paragraph 0084: "A sensor assembly 410 is snap-fit or otherwise held by the sensor assembly support 512. The sensor assembly 410 can also be snap-fit or otherwise held by the platform 408 (e.g., using fingers 414)."; Figure 4), and housing (casing) comprises an interface element (sleeve lock ledge 1018); and
A guide (sleeve 318) for guiding insertion of the sensor into the skin (Paragraph 0105: “the on-body device 222 which is held in the sleeve 318 of the applicator assembly 216”, Paragraph 0106: “Drawings represent an example sequence of driving the sharp 1030 (supporting a sensor coupled to the on-body device 222) into the skin of a user”, and Paragraph 0108: “sleeve 318 collapses into housing 314 driving the on-body device 222”),
Wherein the guide (sleeve 318) is configured to support at least a portion of the sensor,
(Pace teaches an applicator assembly including sleeve 318 that holds an on-body device 222 (Paragraph 0105)). The on-body device includes a sensor coupled to the on-body device that is inserted into the skin of a user (Paragraph 0106). The on-body device carrying the sensor is held within sleeve 318 during insertion, sleeve 318 guides the insertion of the sensor into the skin. Further, since sleeve 318 holds and supports the on-body device that carries the sensor, sleeve 318 supports at least a portion of the sensor. Therefore, sleeve 318 teaches the claims guide configured to guide inserting the sensor into the skin and to support at least a portion of the sensor).
wherein the guide (sleeve 318) comprises a distal end configured to engage the skin to allow distal movement of the housing (housing 314/casing 404) relative to the guide (sleeve 318) and wherein the guide (sleeve 318) comprise a retaining element (sleeve lock arm 1016); (Paragraph 0107, and Fig.11A) (Further, Pace teaches that sleeve 318 functions as the guide for the applicator assembly. The applicator assembly including housing 314/casing 404 move relative to sleeve 318 as the sensor assembly advances toward and into the skin 1104 of the user. (Paragraph,0107-0108). Because the distal portion of sleeve 318 is positioned adjacent the skin during insertion while the housing moves relative to the sleeve (Paragraph 0108, "sleeve 318 collapses into housing 314"), the distal end of sleeve 318 engages the skin and allows distal movement of the housing relative to the guide and guide (sleeve 318) comprises a retaining element (sleeve lock arm 1016))
and wherein the insertion apparatus has a first configuration in which the retaining element of the guide (sleeve 318) is configured to engage with the interface element of the housing (housing 314/casing 404) to resist distal movement of the housing relative to the guide;
(Pace teaches sleeve lock arms 1018 (that functions as a retaining element of the guide (sleeve 318)). As described in Pace, Paragraph 0098 and shown in Fig.10I, the sleeve lock arms 1016 engages a sleeve lock ledge 1018. This engagement locks the applicator assembly 216 and prevent sleeve 318 from being pushed into housing 314, thereby resisting distal movement of the housing relative to the guide. Accordingly, Pace teaches the claimed first configuration in which a retaining element engagement an interface element to resist distal movement).
and wherein the insertion apparatus is configured to move from the first configuration to a second configuration in response to a distal force on the housing above a threshold force, (Paragraph 0096: “the dropping of the unlocked platform 418 is illustrated. FIG. 10G depicts further depression of the applicator assembly 216 in the direction of the longitudinal axis Z.”)
in which the interface element (sleeve lock ledge 1018) is configured to disengage from the retaining element (sleeve lock arm 1016) to distally move the housing (housing 314/casing 404) relative to the guide (sleeve 318) and insert the sensor into the skin. (Paragraph 0100: “the housing 314 of the applicator assembly 216, the carrier 1022, and the electronics assembly 310 are free to continue to descend into the container 206, now that the sleeve 318 is unlocked as shown in FIG. 10L.” and Paragraph 0101: “the sensor assembly 410 is forced into an opening in the electronics assembly 310 which couples the sensor to the electronics and completes assembly of the on-body device 222 (FIG. 2F)”)
Regarding claim 38, Pace teaches wherein the sensor comprises a pointed tip configured to penetrate the skin. (Paragraph 0106 cites “an example sequence of driving the sharp 1030 (supporting a sensor couple to the on-boy device 222) into the skin of a user”).
Regarding claim 39, Pace teaches wherein the sensor comprises a free length portion configured to provide rigidity to facilitate insertion of the sensor into the skin. (Paragraph 0106 cites “an example sequence of driving the sharp 1030 (supporting a sensor couple to the on-boy device 222) into the skin of a user”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2, 3, 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pace in view of Thomas (US 20210161437 A1) and Rao (US20180235520A1).
Regarding claim 2, Pace teaches the insertion apparatus of claim 1 (see rejection of claim 1 above),
Pace teaches wherein the retaining element and interface element are configured to resist distal movement of the housing in response to a distal force on the housing below the threshold force (Pace, 0098, “sleeve lock arms engage a sleeve lock ledge 1018. This engagement locks the applicator assembly 216 and prevents the sleeve 318 from being able to be retracted pushed into the housing 314”).
Pace is silent on wherein the retaining element and interface element are configured to store potential energy. Thomas teaches the retaining element and the interface element are configured to store potential energy. (Thomas, a sharp carrier 5306 and carrier arms 5608 as shown in Figs. 56A-B, and 57A-C that function as detent engagement features known as storing energy). However, Thomas explicitly does not disclose that the retaining element and the interface element are configured to store potential energy. Rao teaches the retaining element and the interface element being configured to store potential energy (Rao disclosing storage of energy in deflected detent snaps 1402 in Figs. 20A-C; Paragraph 0096).
It would have been obvious to a person of ordinary skills in the art to have modified the mechanism of Pace with the teachings of Thomas and Rao to incorporate detent snap features that store energy into Pace’s teaching because detent snap features are well known in the art to store and release energy during engagement and disengagement and it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the interface element and retaining element interaction of Pace with that of Thomas and Rao.
Regarding claim 3, The insertion apparatus of claim 2(see rejection of claim 2 above),
Pace teaches “accelerating the sensor towards the skin” (Paragraph 0106: “Drawings represent an example sequence of driving the sharp 1030 (supporting a sensor coupled to the on-body device 222) into the skin of a user”). Pace teaches the retaining element” and “interface element” without the limitation, “the stored potential energy” (Paragraph 0098: “sleeve unlock features contact and bend the sleeve lock arms 1016 clear of the sleeve lock ledge 1018 thereby unlocking the applicator assembly 216). Furthermore, Pace fails to teach “wherein the stored potential energy is released when the interface element disengages from the retaining element”.
Thomas teaches “the retaining element and the interface element” (Thomas, a sharp carrier 5306 and carrier arms 5608 as shown in Figs. 56A-B, and 57A-C that function as detent engagement features known as storing energy) as disclosed in claim 2. However, Thomas does not explicitly teach “the stored potential energy is released”.
Rao explicitly supports the release of stored potential energy, citing “when a user applies distal pressure to housing 702 while sheath 704 is pressed against the skin, detent snap 1402 passes over firing detent 1344. This begins a firing sequence (as described with respect to FIGS. 20A-C) due to release of stored energy in the deflected detent snaps 1402” (Rao, 0096). In this citation, “detent snap 1402 passes over firing detent 1344” (Rao, 0096) teaches “when the interface element disengages from the retaining element” as recited in this claim 3.
Accordingly, it would have been obvious to a person of ordinary skill in the art to modify Pace with Thomas and Rao and since it would have been obvious that the stored potential energy is released when the interface element disengages from the retaining element, accelerating the sensor towards the skin. because accelerating a sensor into the skin of a user is an inherent reaction result of instantaneous release or rapid transfer of stored energy. Rao further discloses mechanism employing deflectable structures, including but not limited to deflectable detent snaps 1402, deflectable locking arms 1412, sharp carrier lock arms 1524, sharp retention arms 1618, and module snaps 2202, formed from resilient materials capable of storing and releasing potential energy during engagement and disengagement. Such resilient structures are well known to provides restoring forces when deflected (Rao, 0186).
Regarding claim 12, Pace teaches the insertion apparatus of claim 1(see rejection of claim 1 above),
Pace teaches “wherein the guide comprises a retaining element (Paragraph 0107: “The sleeve 318 is held by detent features 1110 within the applicator assembly 216”)” and Pace teaches “when in the second configuration, is configured to engage with the interface element to resist distal movement of the housing relative to the guide (Paragraph 0098: “In FIG. 10I, sleeve lock arms are shown engaged with a sleeve lock ledge 1018. This engagement locks the applicator assembly 216 and prevents the sleeve 318 from being able to be retracted or pushed into the housing 314 of the applicator assembly 216”)”.
However, Pace does not explicitly teach “a second retaining element”. Pace further does not teach “wherein the second retaining element is arranged distally of the retaining element, and wherein the second retaining element,”
Based on the aforementioned 112(f) claim interpretation, the (first) retaining element and the second retaining element have similar shape, structure, and function. The specification supports this interpretation by explaining: “The second retaining element may be similar to the (first) retaining element, and it may comprise similar features such as a protrusion and a recess. The second retaining element can be provided to resist distal movement after full sensor insertion”, thereby, demonstrating that both the first and second retaining elements perform the same function despite being located in slightly different positions.
Thomas further discloses multiple retaining elements (Paragraph, 0629 cites “The sensor carrier 5602 may also include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306.”), thereby, indicating the optional inclusion of multiple retaining elements (deflectable arms).
Rao additionally teaches multiple-stage retention structures in which multiple retaining elements engage corresponding detents to maintain components in position during operation (Paragraph, 00124-00125: “FIG. 10D is a side view of another embodiment of a two-piece sharp carrier assembly, consisting of inner sharp carrier 4102 and outer sharp carrier 4152. Similar to the previous embodiment, inner sharp carrier 4102 can include one or more sharp retention arms 4104 with sharp retention clips 4106, and one or more inner carrier latches 4110 at or near a proximal end of inner sharp carrier 4102”).
Accordingly, it would have been obvious to a person of ordinary skill in the art to modify Pace with Thomas and Rao to include a second retaining element, to “be arranged distally of the retaining element, and wherein the second retaining element, when in the second configuration, is configured to engage with the interface element to resist distal movement of the housing relative to the guide” because The first and second retaining element structurally and functionally are similar, and this modification, adding the second retaining element, is merely a duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 13, Pace in view of Thomas and Rao teach the insertion apparatus of claim 12(see rejection of claim 12 above).
Pace does not teach that “wherein an axial distance between the retaining element and the second retaining element corresponds to” although Pace teaches “a distance for movement of the housing for insertion of the sensor into the skin” (Paragraph, 0107: “appropriate downward force along the longitudinal axis of the applicator assembly 216 will cause the resistance provided by the detent features 1110 to be overcome so that the sharp 1030 and on-body device 222 can translate along the longitudinal axis into (and onto) the skin”) . Pace does not explicitly teach “the second retaining element”.
Based on the aforementioned 112(f) claim interpretation, the (first) retaining element and the second retaining element have similar shape, structure, and function. The specification supports this interpretation by explaining: “The second retaining element may be similar to the (first) retaining element, and it may comprise similar features such as a protrusion and a recess. The second retaining element can be provided to resist distal movement after full sensor insertion”, thereby, demonstrating that both the first and second retaining elements perform the same function despite being located in slightly different positions.
Thomas further discloses multiple retaining elements (Thomas, 0629 cites “The sensor carrier 5602 may also include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306.”), thereby, indicating the optional inclusion of multiple retaining elements (deflectable arms).
It would have been obvious to a person of ordinary skill in the art to incorporate the second retaining element into the insertion apparatus since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).”
Regarding claim 14, Pace in view of Thomas and Rao teach the insertion apparatus of claim 13(see rejection of claim 13 above).
Pace teaches the insertion apparatus of claim 13, wherein the guide comprises a retaining element, wherein the housing comprises an interface element, (Paragraph 0107: “The sleeve 318 is held by detent features 1110 within the applicator assembly 216”).
Pace teaches wherein the retaining element, when in the second configuration, is configured to engage with the interface element to resist proximal movement of the housing relative to the guide (Paragraph 0098: “In FIG. 10I, sleeve lock arms are shown engaged with a sleeve lock ledge 1018. This engagement locks the applicator assembly 216 and prevents the sleeve 318 from being able to be retracted or pushed into the housing 314 of the applicator assembly 216”).
However, Pace does not explicitly teach “a third retaining element” nor “a second interface”. Pace does not teach “third retaining element, when in the second configuration, is configured to engage with the second interface element,”
Based on the aforementioned 112(f) claim interpretation, the (first) retaining element and the third retaining element have similar shape, structure, and function. The specification supports this interpretation by explaining: “The third retaining element may be similar to the (first) retaining element, and likewise the second interface element similar to the (first) interface element. they may comprise similar features such as a protrusion and a recess.
Supportively Thomas discloses multiple retaining elements (Thomas, Paragraph 0629 cites “The sensor carrier 5602 may also include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306.”), thereby, indicating multiple retaining elements or interface elements (e.g., deflectable arms) may be provided.
Rao additionally teaches multiple-stage retention structures in which multiple retaining elements engage corresponding detents to maintain components in position during operation (Paragraph, 00124-00125: “FIG. 10D is a side view of another embodiment of a two-piece sharp carrier assembly, consisting of inner sharp carrier 4102 and outer sharp carrier 4152. Similar to the previous embodiment, inner sharp carrier 4102 can include one or more sharp retention arms 4104 with sharp retention clips 4106, and one or more inner carrier latches 4110 at or near a proximal end of inner sharp carrier 4102”).
It would have been obvious to a person ordinary skill in the art to modify Pace with Thomas and Rao to include a third retaining element configured to engage a second interface element in the second configuration to resist proximal movement of the housing relative to the guide in order to control axial movement of the housing during insertion and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 15, Pace in view of Thomas and Rao teaches the insertion apparatus of claim 14 (see rejection of claim 14 above),
Pace is silent on wherein the housing comprises a second deflectable arm, wherein the second interface element comprises an end of the second deflectable arm.
Thomas discloses wherein the housing comprises a second deflectable arm, and wherein the second interface element comprises an end of the second deflectable arm. (Paragraph 0630: “thereby force the carrier arm(s) 5608 out of engagement with the groove(s) 5610, which allows the sharp carrier 5306 to move slightly upward within the housing”) and Thomas further teaches “a deflectable arm” as shown in Fig. 56A-B and 57A-B and :Paragraph 0629: “The sensor carrier 5602 may also include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306”).
Based on the aforementioned 112(f) claim interpretation, the (first) retaining element and the third retaining element have similar shape, structure, and function. The specification supports this interpretation by explaining: “The third retaining element may be similar to the (first) retaining element, and likewise the second interface element similar to the (first) interface element. they may comprise similar features such as a protrusion and a recess.
Supportively Thomas discloses multiple retaining elements (Thomas, Paragraph 0629 cites “The sensor carrier 5602 may also include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306.”), thereby, indicating multiple retaining elements or interface elements (e.g., deflectable arms) may be provided.
Rao additionally teaches multiple-stage retention structures in which multiple retaining elements engage corresponding detents to maintain components in position during operation (Paragraph, 00124-00125: “FIG. 10D is a side view of another embodiment of a two-piece sharp carrier assembly, consisting of inner sharp carrier 4102 and outer sharp carrier 4152. Similar to the previous embodiment, inner sharp carrier 4102 can include one or more sharp retention arms 4104 with sharp retention clips 4106, and one or more inner carrier latches 4110 at or near a proximal end of inner sharp carrier 4102”).
It would have been obvious to person of ordinary skills in the art to modify Pace with Thomas such that the housing comprises a second deflectable arm, and wherein the second interface element comprises an end of the deflectable arm because integrating the interface element into the end of deflectable arms and incorporating deflectable arms into the housing, such modification, represents a predictable design choice and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pace in view of Griffin (J. Vs. Exp (118), e54872, 2016).
Regarding claim 4, Pace teaches the insertion apparatus of claim 1(see rejection of claim 1 above),
Pace teaches wherein the distal end of the guide is configured to act against the skin in response to the distal force to provide a restoring force for engaging the retaining element with the interface element when the distal force is below the threshold force, and for allowing the housing to distally move relative to the guide when the distal force is above the threshold force. (Pace, 0011: “the system also includes an applicator assembly that has a sleeve defining a distal surface for placement on the skin of the subject”, Pace, 0107: “Turning now to FIG. 11A, a sensor 1102 is supported within sharp 1030, just above the skin 1104 of the user” as shown in FIG. 11A, Pace, 0098: “In FIG. 10I, sleeve lock arms are shown engaged with a sleeve lock ledge 1018. This engagement locks the applicator assembly 216 and prevents the sleeve 318 from being able to be retracted or pushed into the housing 314 of the applicator assembly 216.”, Pace, 0108: “In FIG. 11B, user force is applied to overcome or override detent features 1110 and sleeve 318 collapses into housing 314 driving the on-body device 222 (with associated parts) to translate down as indicated by the arrow L along the longitudinal axis”, and
Pace, 0111:” The user does not perceive that he is supplying additional force to drive the sharp 1030 to pierce his skin despite that all the driving force is provided by the user and no additional biasing/driving means are used to insert the sharp 1030. As detailed above in FIG. 11C, the retraction of the sharp 1030 is automated by the coil return spring 1118 of the applicator 216)
However, Pace is silent on “act against the skin in response to the distal force to provide a restoring force”, specifically, “restoring force”.
Griffin (J. Vs.Exp (118), e54872, 2016) teaches biomechanical properties of skin tissue, including (Young’s elastic modulus (pp3-6, Fig. 5), demonstrating a proportional relation between stress and strain and implicating skin’s restoring force when deformed.
Therefore, It would have been obvious to a person of ordinary skills in the art to have modified the mechanism of Pace in view of the teaching of Griffin that the distal end of the guide is configured to act against the skin in response to the distal force to provide a restoring force below the threshold force because when the applied force is below the threshold, the deformable skin elastically deforms and generates a restoring force that biases the guide back, as understood from the known biomedical properties of skin.
Claim 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Pace.
Regarding claim 5, Pace teaches the insertion apparatus of claim 1(see rejection of claim 1 above),
Pace does not explicitly teach that “the interface element is arranged on the device carrier”.
Pace discloses “the sleeve lock ledge 1018 (which functions as the claimed interface element) is formed in a carrier 1022 of the electronics assembly 310” (Pace, 0098).
It would have been obvious to a person of ordinary skill in the art to arrange the interface on the device carrier as taught by Pace in order to reliably control engagement and disengagement of the retaining mechanism during operation and since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Regarding claim 6, Pace teaches the insertion apparatus of claim 1(see rejection of claim 1 above),
Pace does not explicitly teach that “the interface element is arranged on the cover”.
Pace discloses that “platform locking arm 504 and detent arms 1008 engages undercut grooves 1028 in the container 206, locking the platform 418 in the casing 404” (Pace, 0104).
It would have been obvious to a person of ordinary skills in the art to arrange the interface element is arranged on the cover as taught by Pace in order to reliably control engagement and disengagement of the retaining mechanism during operation and since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Claim 7, 8, 9, 10, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Pace in view of Thomas.
Regarding claim 7, Pace teaches the insertion apparatus of claim 1(see rejection of claim 1 above),
Pace dose not explicitly teach that “the retaining element comprises a protrusion extending laterally from the guide”. Thomas illustrates Fig. 56A-B and 57A-B, which explicitly shows an extrusion at the end of carrier arms 5608 acting as interface element.
Pace teaches “configured to resist distal movement of the interface element” (Paragraph 0104: “platform locking arms 504 and detent arms 1008 have engaged undercut grooves 1028 in the container 206, thereby locking the platform 418 in the casing 404” and Paragraph 0098: “sleeve lock arms are shown engaged with a sleeve lock ledge 1018. This engagement locks the applicator assembly 216 and prevents the sleeve 318 from being able to be retracted or pushed into the housing 314”).
However, Pace does not explicitly teach that “the interface element is arranged proximally of the protrusion in the first configuration and the protrusion is configured to resist distal movement of the interface element”.
Thomas discloses Figs. 56A-B,57A-B, showing resisting distal of the protrusion, and
Thomas additionally discloses that “one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306”, demonstrating a proximal arrangement of the protrusion on the interface element relative to a recess on the retaining element.
Therefore, it would have been obvious to a person of ordinary skills in the art to modify Pace with Thomas to incorporate the retaining element comprising a protrusion taught by Thomas into Pace's teaching in order to improve reliability and stability of engagement between the interface element and the retaining element during operation. Specifically, Thomas teaches carrier arms 5608 configured to interact with a corresponding one or more grooves 5610 (Paragraph, 0629), which provide a more secure mechanical interlock that resist unintended distal movement. Such an arrangement enhances retention by ensuring controlled positional interaction between components.
A person of ordinary skills in the art would have been motivated to incorporate this feature into Pace’s device because improving resistance to distal movement and ensuring consistent engagement are known design consideration in retention mechanisms, thereby yielding a more robust and reliable assembly.
Regarding claim 8, Pace in view of Thomas teaches the insertion apparatus of claim 7(see rejection of claim 7 above),
Pace is silent on that the interface element is to configured to deflect over the protrusion to move. Thomas teaches that “the interface element is configured to deflect over the protrusion to move to the second configuration when the distal force is above the threshold force” (Paragraph 0637: “moving the sheath 212 upward causes the sheath arms 5604 to flex out of engagement with the first detent 5702 a to be received within the second detent 5702 b”; Figs. 56A-B,57A-B, showing resisting distal of the protrusion and demonstrating that a deflectable interface element can be incorporated to disengage with corresponding retaining element; Paragraph 0722; Also Examiner notes deflecting over the protrusion is an inherent result of exceeding threshold force to move to a second configuration.).
Therefore, it would have been obvious to a person of ordinary skills in the art to modify Pace in view with Thomas to incorporate the snap-it retaining element (“deflect over the protrusion”) taught by Thomas into Pace's teaching. Thomas teaches deflectable arms and detent features that enable controlled disengagement upon exceeding a threshold force (Paragraph 0630, 0722). Incorporating this structure into Pace would predictably provide a reliable disengagement mechanism with a defined force threshold.
Regarding claim 9, Pace in view of Thomas teaches the insertion apparatus of claim 7(see rejection of claim 7 above),
Pace does not explicitly teach “wherein the retaining element comprises a recess adjacent to and proximally of the protrusion”. Thomas illustrates Fig. 56A-B and 57A-B, which explicitly shows a recess at groove(s) defined on the sharp carrier 5306.
Pace does not teach “wherein the recess is configured to receive the interface element in the first configuration to resist distal movement of the interface element.”. Thomas teaches “one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306.” (Paragraph, 0629) and teaches “When the carrier arm(s) 5608 are properly received within the groove(s) 5610, however, the sharp carrier 5306 is maintained in position” (Paragraph, 0629)
It would have been obvious to person of ordinary skills in the art to modify Pace in view with Thomas that the retaining element comprises a recess adjacent to and proximally of the protrusion and the recess is configured to receive the interface element because integrating a recess into the retaining element, such modification, represent a predictable design choice. Thomas further teaches relocation of flexible retention arms to achieve more compact applicator design, citing that “the features of the sensor retainer 7100 enable a more compact applicator design by replacing the flexible arms of conventional sensor retainers. By relocating the flexible retention arms to the apertures 6215, 7104, the overall size of the sensor applicator may be reduced.” (Paragraph 0722).
Regarding claim 10, Pace in view of Thomas teaches the insertion apparatus of claim 9(see rejection of claim 9 above),
Pace does not teach wherein the interface element is configured to deflect out of the recess to move to the second configuration when the distal force is above the threshold force.
Thomas teaches wherein the interface element is configured to deflect out of the recess to move to the second configuration when the distal force is above the threshold force.(Paragraph, 0722: that “the sheath arms 5604 to flex out of engagement with the first detent 5702 a to be received within the second detent 5702 b”, and Paragraph, 0630: “Continued pressure on the sensor applicator 102 against the skin may cause the sheath arm(s) 5604 to disengage from the corresponding detent(s) 5606, which allows the sheath 212 to collapse into the housing 208”).
It would have been obvious to a person of ordinary skill in the art to modify Pace with Thomas to incorporate “configured to deflect out of recess to move” to the engagement of interface element and the recess in response to threshold force to facilitate reliable transition between engaged and disengaged state during operation. Such configuration enables the interface element to maintain secure engagement during positioning while allowing disengagement upon application of a sufficient distal force, thereby improving control over actuation of the insertion apparatus. The use of deflectable element, such as detents or snap-fit features, to provide reversible engagement under an applied force is a well-know and predictable design approach in mechanical and medical devices (Paragraph, 0063 and 0722).
Regarding claim 11, Pace teaches the insertion apparatus of claim 1(see rejection of claim 1 above),
Pace is silent on wherein the housing comprises a deflectable arm, and wherein the interface element comprises an end of the deflectable arm.
Thomas discloses wherein the housing comprises a deflectable arm, and wherein the interface element comprises an end of the deflectable arm. (Paragraph 0630: “thereby force the carrier arm(s) 5608 out of engagement with the groove(s) 5610, which allows the sharp carrier 5306 to move slightly upward within the housing”) and Thomas further teaches “a deflectable arm” as shown in Fig. 56A-B and 57A-B.
It would have been obvious to person of ordinary skills in the art to modify Pace in view with Thomas that the housing comprises a deflectable arm, and wherein the interface element comprises an end of the deflectable arm because integrating the interface element into the end of deflectable arms and incorporating deflectable arms into the housing, such modification, represents a predictable design choice. To support this rationale, Thomas further teaches relocation of flexible retention arms to achieve more compact applicator design, citing that “the features of the sensor retainer 7100 enable a more compact applicator design by replacing the flexible arms of conventional sensor retainers. By relocating the flexible retention arms to the apertures 6215, 7104, the overall size of the sensor applicator may be reduced.” (Paragraph 0722)
Regarding claim 16, Pace teaches the insertion apparatus of claim 1 (see rejection of claim 1 above),
Pace does not teach “biasing element configured to bias the interface element against the guide” although Pace teaches “the sleeve 318 of the applicator assembly 216 is fully unlocked, the momentum along the longitudinal axis Z (FIG. 10F) from the force used to overcome the resistance of the detent features 1006 (FIG. 10H) causes three additional concurrent actions” (Pace, Paragraph 0100). However, Pace does not explicitly disclose a biasing element such as a spring to the sleeve 318, acting as the guide.
Thomas discloses that “The sensor carrier 5602 may also include one or more carrier arms 5608 (one shown) configured to interact with a corresponding one or more grooves 5610 (one shown) defined on the sharp carrier 5306. A spring 5612 may be arranged within a cavity defined by the sharp carrier 5306 and may passively bias the sharp carrier 5306 upward within the housing 208” (Thomas, Paragraph 0629), demonstrating that “biasing element configured to bias the interface element against the guide”.
It would have been obvious to a person of ordinary skill in the art to modify Pace with Thomas to incorporate such a known spring biasing mechanism into the apparatus of Pace to maintain engagement between the interface element against the guide and maintain engagement prior to release. On top of that, Rao teaches the force is continuously applied and keeps components engaged, preventing from unwanted movement (Rao, US20180235520A1, Paragraph, 0101: Upon detent round 6404 advancing into two-way lockout recess 7336, sheath 6704 can be prevented from further movement in either a proximal or distal direction. This can reduce unwanted movement of sheath 6704 during the sensor insertion process).
Claim 1, 35, 36 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (US US20180235520A1) in view of Pace.
Regarding claim 1, Rao teaches an insertion apparatus for inserting a sensor into skin of a subject (Paragraph 0067), comprising:
Rao teaches that a sensor control device (sensor control device 102, Fig. 1,3F,12A-B) comprising a sensor (sensor 104, Fig.12A-B)(Paragraph, 0008: “After assembly, the applicator can be used to position the sensor control device on a human body with a sensor in contact with the wearer's bodily fluid (e.g., dermal fluid)”), and teaches that wherein the sensor is configured to penetrate the skin of the subject (Paragraph, 0067: “systems, devices, and methods for the use of dermal sensor insertion applicators for use with in vivo analyte monitoring system” and Paragraph, 0159: “Sharp 2552 and sensor 104 have extended from the distal end of sheath 704 and have already penetrated, or are in the process of penetrating, the subject's skin layer”).
Rao teaches “a housing (housing 702)” and “a device carrier (Sensor electronics carrier 6710) (Paragraph, 0096: “As housing 702 moves further in a proximal direction toward the skin surface” and Paragraph, 0110: “Turning to FIG. 8G, sheath 6704 is shown in perspective view in a stage of assembly with applicator housing 6702 and sensor electronics carrier 6710”).
However, Rao is silent on “cover” and further “comprising a cover and a device carrier (Sensor electronics carrier 6710) coupled to the cover”.
Pace teaches a housing comprising a cover” (Paragraph, 0084: "In reference to FIG. 4, the container 206 includes a cover 402 (e.g., made of a removable material such as foil)”.
Rao is silent on wherein the device carrier (Sensor electronics carrier 6710) is configured to releasably retain the sensor control device (sensor control device 102).
Pace cites that "A sensor assembly 410 is snap-fit or otherwise held by the sensor assembly support 512. The sensor assembly 410 can also be snap-fit or otherwise held by the platform 408 (e.g., using fingers 414)". Rao teaches “wherein the housing comprises an interface element (detent snap flat 1406)” (Paragraph, 0096: “after detent snap 1402 passes, engages a detent snap flat 1406 and prevents reuse of the device by securely holding sheath 704 in place with respect to housing 702”).
Rao teaches a guide (guide rib 1321) for guiding insertion of the sensor into the skin, demonstrating that guide rib 1321 (including rib 1340 or 6340) could act as the guide (Figs. 7C-I, and Paragraph, 0094: “Each guide rib 1321 includes a guide edge (also called a “sheath guide rail”) 1326 that can pass along a surface of sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A)”, and demonstrating “guiding insertion of the sensor into skin”(Paragraph, 0110: The fitted interface between corresponding ribs 6425 and notches 6519 can help maintain axial alignment of the sheath 6704 and sensor electronics carrier 6710 during the sensor insertion process, and Paragraph, 0159: Sharp 2552 and sensor 104 have extended from the distal end of sheath 704 and have already penetrated, or are in the process of penetrating, the subject's skin layer”).
Rao further teaches wherein the guide (guide rib 1321) is configured to support at least a portion of the sensor (Paragraph, 0103: “Guide rails 1418 are disposed between sensor electronics carrier”).
Rao teaches “the guide (guide rib 1321)” features (Figs. 7C-I and Paragraph, 0094: “each structure 1321 and 1340 is configured as a planar rib, although other shapes can be used. Each guide rib 1321 includes a guide edge (also called a “sheath guide rail”) 1326 that can pass along a surface of sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A)”).
Rao further teaches that a distal end configured to engage the skin to allow distal movement of the housing relative to the guide ((Paragraph, 0098: As force is applied to the proximal end of housing 2702, detent round 1404 (retaining element part) is advanced into unlocked groove 2334, placing applicator 150 into the “armed” position. When force is further applied to the proximal end of housing 2702, applicator 150 is “fired,” as detent round 1404 passes over firing detent 2344.” and Paragraph, 0167: “as shown in call-out 14B-2, sensor electronics carrier 6710 moves in a distal direction (i.e., towards the skin) relative to housing 7702”).
Rao teaches “a first configuration in which the retaining element (lockout recess 1336, a part of rib 1340) of the guide is configured to engage with the interface element (detent round 1404, a part of detent snap 1402) of the housing” (Figs. 7C-I and Paragraph, 0097: “Upon detent round 1404 reaching final lockout recess 1336, detent snap flat 1406 (not shown) is engaged and securely holds sheath 704 in place with respect to housing 702”).
Rao further teaches “to resist distal movement of the housing relative to the guide” (Paragraph, 0096: “after detent snap 1402 passes, engages a detent snap flat 1406 and prevents reuse of the device by securely holding sheath 704 in place with respect to housing 702”).
Rao teaches “configured to move from the first configuration to a second configuration” (Paragraph, 0097: “When force is further applied to the proximal end of housing 702, applicator 150 is “fired,” as detent round 1404 is advanced proximally from the unlocked groove 1334 and passes over firing detent 1344. Thereafter, sheath 704 is further advanced proximally such that detent round 1404 is slidably advanced over firing surface 1337”) and further teaches in response to a distal force on the housing above a threshold force (Paragraph, 0097: “as detent round 1404 is advanced proximally from the unlocked groove 1334 and passes over firing detent 1344. Thereafter, sheath 704 is further advanced proximally such that detent round 1404 is slidably advanced over firing surface 1337”).
Rao teaches the interface element (detent round 1404, a part of detent snap 1402) is configured to disengage from the retaining element (unlocked groove 1334, a part of rib 1340) (Paraph, 0097: as detent round 1404 is advanced proximally from the unlocked groove 1334 and passes over firing detent 1344. Thereafter, sheath 704 is further advanced proximally such that detent round 1404 is slidably advanced over firing surface 1337), and further teaches to distally move the housing relative to the guide and insert the sensor into the skin (Paragraph, 0167: “as shown in call-out 14B-2, sensor electronics carrier 6710 moves in a distal direction (i.e., towards the skin) relative to housing 7702”).
It would have been obvious to a person of ordinary skill in the art to modify Rao with Pace to incorporate Pace’s cover into Rao’s housing and to couple the device carrier to the cover using known coupling techniques thus through routine experimentation one could expect predictable results. Pace teaches a housing comprising a cover (402) and further teaches coupling components via snap-fit (Paragraph 0084: "A sensor assembly 410 is snap-fit or otherwise held by the sensor assembly support 512. The sensor assembly 410 can also be snap-fit or otherwise held by the platform 408 (e.g., using fingers 414).")
Regarding claim 35, Rao in view of Pace teaches the insertion apparatus of claim 1 (see second rejection of claim 1 above),
Rao teaches comprising a sheath (sheath 704) slidably moveable relative to the housing (Paragraph, 0083: “Inserting sheath 704 into platform 808 temporarily
unlocks sheath 704 relative to housing 702” and Paragraph, 0084: Sheath 704 can maintain position within platform 808 with respect to housing 702).
And Rao further teaches wherein the sheath comprises a distal end configured to engage the skin (Paragraph, 0086: “Advancing housing 702 distally collapses sheath 704 within housing 702 and applies the sensor to the target location such that an adhesive layer on the bottom side of sensor control device 102 adheres to the skin”).
Regarding claim 36, Rao in view of Pace teaches the insertion apparatus of claim 35 (see rejection of claim 35 above),
Rao further teaches “wherein the housing (housing 702) is configured to distally move relative to the sheath (Sheath 704) in response to a second distal force on the housing.” (Paragraph, 0097: As housing 702 moves further in a proximal direction toward the skin surface, and as sheath 704 advances toward the distal end of housing 702, detent snaps 1402 shift
into the unlocked grooves 1334”).
Accordingly, it would have been obvious to a person of ordinary skill in the art to modify Rao to incorporate housing configured to distally move relative to the sheath in response to a second distal force on the housing.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Rao (US US20180235520A1) in view of Pace and Donnay (US 20120303043 A1).
Regarding claim 37, Rao in view of Pace teaches the insertion apparatus of claim 36 (see rejection of claim 36 above),
Rao teaches “wherein distally moving the housing relative to the sheath” (Paragraph, 0113: “When housing 702 has been moved further distally with respect to sheath 704 to shift detent snaps 1402 into the un-locked grooves 1334”).
However, Rao is silent on “comprises moving the distal end of the guide into contact with the skin before the movement from the first configuration to the second configuration”.
Donnay teaches “the guide (carrier 2730)” (Paragraph, 0145, “Referring next to FIGS. 32-33, depicted is sharp carrier 2716 in a perspective and cross-sectional view, respectively. Sharp carrier 2716 contains notches 2724 which allow clearance for the passage of carrier arms 2732 located on medical device carrier 2730”). Further, Donnay teaches ”comprises moving the distal end of the guide into contact with the skin before the movement from the first configuration to the second configuration” (Paragraph, 041: “housing 2702 is advanced relative to sheath 2708 in order to advance the medical device distally and into the skin of the patient”, Paragraph, 0142: “Sheath 2708, sharp carrier 2716, and housing 2702 may alternatively move relative to one another without the use of guide rails”, and Paragraph, 0151:” As carrier 2716 reaches a distal position, the distal surface of the on-body housing 122 engages the upper surface of adhesive pad 118, thereby becoming adhered to the skin surface S of the subject”).
It would have been obvious to a person of ordinary skill in the art to modify Rao in view of Donnay to incorporate Donnay’s guide (carrier 2730) into Rao’s because such substitution improves alignment and positioning of the insertion apparatus relative to the skin prior to insertion. Such a substitution would ensure that the distal end of the guide contacts the skin, thereby stabilizing the device and enabling more accurate and controlled insertion of the sensor. Incorporating guiding structure to control positioning and movement along an insertion path is a well-known and predictable design consideration in the art.
Conclusion
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/MORGAN SANGJO SHIM/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791