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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 7-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Rao (US 20220125480 A1) (hereinafter – Rao).
Re. Claim 1: Rao teaches an insertion system (Paragraph 0002: “The subject matter described herein relates generally to systems, devices, and methods of using an applicator to insert at least a portion of an analyte sensor in a subject”)
comprising:
at least one screw coupling configured for coupling at least one first element and at least one second element of the insertion system (Fig. 26B: combination of housing 208 and sleeve 212 can be considered a first element, and an applicator cap 210 may be considered a second element, whereby both are coupled via threads, as described in Paragraph 0229: “…the threads of the applicator cap 210 may be snapped onto the corresponding threads of the housing 208 to couple the applicator cap 210 to the housing 208;” Figs. 4A-4C: threads of housing 702 are follow a helical screw-like track),
wherein the screw coupling is configured such that the first element and the second element are assembled without rotational movement (see previous citation – “snapped” implies coupling without rotation), and
wherein the screw coupling comprises:
at least one radially flexible part configured for radial movement and/or radial deformation when assembling the first element and the second element together, wherein the radially flexible part is a part of the first element or the second element (see previous citation – “snapped” implies coupling via elastic radial deformation; Fig. 26B, as described in Paragraph 0229: “Axial cuts or slots 5703 (one shown) defined in the applicator cap 210 may allow portions of the applicator cap 210 near its threading to flex outward to be snapped into engagement with the threading of the housing 208”); and
elastic means configured for applying a force in an axial direction to the screw coupling, wherein the elastic means is pre-loadable in the axial direction during assembly of the insertion system (Figs. 40A-40E: action of spring 1118 imparts a force in the axial direction to the screw coupling identified in previous citations; Examiner notes that the spring 1118 is initially compressed, i.e., pre-loaded; see reset tool used in Figs. 42D-42L, compressing spring 1118 to enable reuse).
Re. Claim 2: Rao teaches the invention according to claim 1, and further teaches the invention wherein the elastic means comprises at least one spring element and/or at least one elastic arm (Figs. 40A-40E, 42D-42L: spring 1118).
Re. Claim 3: Rao teaches the invention according to claim 1, and further teaches the invention wherein the insertion system comprises a housing, wherein the housing comprises at least one opening, wherein the elastic means is pre-loadable via the opening of the housing (see reset tool used in Figs. 42D-42L, compressing spring 1118 to enable reuse).
Re. Claim 4: Rao teaches the invention according to claim 3, and further teaches the invention wherein the opening is configured such that an external force can be applied in an axial direction to the elastic means (see reset tool used in Figs. 42D-42L, compressing spring 1118 to enable reuse).
Re. Claim 5: Rao teaches the invention according to claim 1, and further teaches the invention wherein the screw coupling is configured for preventing axial movement of the first element and the second element (Paragraph 0229: “…the threads of the applicator cap 210 may be snapped onto the corresponding threads of the housing 208 to couple the applicator cap 210 to the housing 208;” Examiner notes that snapping threads of one element into threads of another prevents further significant axial movement beyond an area where threaded surfaces meet).
Re. Claim 7: Rao teaches the invention according to claim 1, and further teaches the invention wherein the insertion system comprises a housing, wherein
the first element is a guide sleeve (Fig. 26B: sleeve 212 comprises a “first element” identified in citations of the rejection of claim 1)
and the second element is a protective cap of the housing (Fig. 26B: an applicator cap 210 may be considered protective of elements which it is covering, and thus may be considered a protective cap of the housing),
wherein the housing further comprises an insertion cap (Fig. 26B: see upper portion of housing 208, which may be considered a cap; Examiner notes that the entirety of the device is an insertion device; thus, a cap thereof may be considered an insertion cap).
Re. Claim 8: Rao teaches the invention according to claim 7, and further teaches the invention wherein the housing comprises at least one opening (Fig. 42C: reset channel 217b),
wherein the elastic means is pre-loadable via the opening (see actions of Figs. 42E-42K),
wherein the opening is defined by the insertion cap (Figs. 42C-42K: upper part of applicator 217 may be considered a cap of an insertion device, whereby reset channel 217b is located in the upper part of applicator 217),
wherein the elastic means is coupled to the guide sleeve (Fig. 42E: spring 1118 is coupled to sleeve 318; see also action in Figs. 40A-40E), and
wherein the elastic means is positioned on an inner surface of the insertion cap (Fig. 42E: spring 1118 is also located within applicator 217, i.e., an insertion cap; see also Fig. 40: fully extended spring makes contact with upper portion of housing 314).
Re. Claim 9: Rao teaches the invention according to claim 1, and further teaches the invention wherein the insertion system is configured for inserting at least one medical device into a body tissue of a user, wherein the medical device comprises at least one device selected from the group consisting of an analyte sensor for detecting at least one analyte in a body fluid of a user and an infusion cannula (Paragraph 0005: “The application process includes inserting at least a portion of a sensor that senses a user's analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes into contact with a bodily fluid”).
Re. Claim 10: Rao teaches the invention according to claim 1, and further teaches the invention wherein each of the first element and the second element comprises a thread (Paragraph 0229: “…the threads of the applicator cap 210 may be snapped onto the corresponding threads of the housing 208 to couple the applicator cap 210 to the housing 208;” Figs. 4A-4C: threads of housing 702 are follow a helical screw-like track),
wherein the screw coupling is configured for coupling the first element and the second element by pressing one of the first element and the second element relative to the other one of the first element and the second element (see previous citation),
wherein the radially flexible part is configured for radial movement and/or radial deformation when coupling the first element and the second element (Paragraph 0229: “Axial cuts or slots 5703 (one shown) defined in the applicator cap 210 may allow portions of the applicator cap 210 near its threading to flex outward to be snapped into engagement with the threading of the housing 208”).
Re. Claim 11: Rao teaches the invention according to claim 1, and further teaches the invention wherein one of the first element and the second element comprises the radially flexible part, wherein the other one of the first element and the second element comprises at least one groove for interlocking with at least one element of the radially flexible part and at least one protrusion element configured for applying a radial force on the radially flexible part when coupling the first element and the second element (see citations of rejection of claim 10).
Re. Claim 12: Rao teaches the invention according to claim 1, and further teaches the invention wherein the screw coupling comprises at least one stop configured for at least partially blocking relative axial movement of the first element and the second element (Fig. 22C: see portions of applicator cap 210 contacting portions of housing 208 along threaded portions; additionally, see Figs. 41A, 41B at circled portions and 2002D).
Re. Claim 13: Rao teaches the invention according to claim 1, and further teaches the invention wherein the screw coupling is configured for detachably coupling the first element and the second element (see citation of Paragraph 0229 in rejection of claim 1 – “snapped” implies coupling via elastic radial deformation; elastic deformation implies detachability; Examiner notes Applicant’s definition of “detachably coupling” also includes “deformation and/or destruction of at least one of the first element and the second element” (Specification, Paragraph 0042); thus, destruction of the device of Rao itself also constitutes detachable coupling).
Re. Claim 14: Rao teaches a kit comprising at least one insertion system according to claim 1 (see rejection of claim 1) and means to preload the elastic means during assembly (Figs. 42A-42O).
Re. Claim 15: Rao teaches method for assembling the first element and the second element of the at least one insertion system using the kit according to claim 14 (see rejection of claim 14), wherein the method comprises the following steps:
applying an external force on the elastic means using the means to preload, wherein the external force acts in an axial direction (Figs. 42A-42O);
assembling by a strictly axial movement the first element and the second element, wherein the assembling comprises interlocking the first element and the second element by using at least one radially flexible part (Fig. 42O: sensor tray 810; see citations of rejection of claim 1 regarding snap-fit of applicator cap 210); and
withdrawing the external force on the elastic means (Figs. 42K-42L).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is as follows:
Rao (US 20220125480 A1) (hereinafter – Rao)
Stafford et al. (US 20080114280 A1) (hereinafter – Stafford)
Halac et al. (WO 2017116915 A1) (hereinafter – Halac)
Baker et al. (US 20180360493 A1 ) (hereinafter – Baker)
Donnay et al. (EP 4248866 A2) (hereinafter – Donnay).
Claim 6 requires:
“wherein the elastic means is configured for driving at least one axial and relative movement of the first element and the second element when an external force on the elastic means is withdrawn such that the first element and the second element are positioned axially and rotationally with respect to each other.”
What is identified as an elastic means by Rao is a spring 1118 used to retract a sharp 1030 (Figs. 40A-40E), which is not in contact with any portion of applicator cap 210 (i.e., “second element”). Thus, the elastic means identified in Rao is not configured for driving at least one axial and relative movement of the first element and the second element when an external force on the elastic means is withdrawn. No other component of Rao teaches or suggests such an elastic means or claimed function therewith, nor does any prior art of record teaches or suggests the limitations of claim 8.
None of the other prior arts of record identified above teach or suggest such the claimed feature identified above.
Stafford does not teach the use of screw threads for coupling a first element (Fig. 1: inserter 310) to a second element (Fig. 1: mount 312), nor is it clear that springs 336, 342 (Fig. 8) apply a force against the second element to drive relative axial movement when an external force is withdrawn.
Halac, Baker, and Donnay also do not disclose structures which encompass the claimed subject matter. In each of these references, a spring appears to act on a sheath/sleeve; in either case, neither the sheath/sleeve nor the inserter/housing/body appears to possess a screw coupling having “at least one radially flexible part configured for radial movement and/or radial deformation when assembling the first element and the second element together, wherein the radially flexible part is a part of the first element or the second element” as required in claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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