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 .
Priority
Claims 1-11 are deemed to have an effective filing date of August 12, 2021 for examination purposes.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application so that the instant application has the earlier filing date of the Korean patent application because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 7, includes the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claim 5 appears to be a literal translation into English from a foreign document. Consequently, the scope of claim 5 is indefinite as it is unclear what is intended by: “the operation portion is configured to be movable in a direction of intersecting a direction a movement of the insertion portion by the insertion unit”. What is intended by “a direction of intersecting a direction a movement”?
With respect to claim 8, line 3, there is insufficient antecedent basis for “the basic unit” as the element had not been mentioned earlier. What is “the basic unit” referring back to? In line 8 of claim 8, there is confusion as to the subject of “release restraint”. If the subject is intended to be “the locking hook”, the verb should be singular (i.e., releases).
Claims 2-4, 6-7, and 9-10 are rejected because they depend from an indefinite claim.
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 1-6 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2016/0058474 to Peterson et al. (hereinafter referred to as “Peterson”).
Regarding claim 1, Peterson discloses an applicator for a medical device for attaching the medical device to skin of a user (e.g., title and paragraph [0002]: invention relates to an inserter assembly for continuous glucose monitoring in a patient), comprising: an applicator body (e.g., paragraph [0132]: inserter assembly/applicator 200 incudes a housing body 202; Fig. 9, 202); an insertion unit installed at the applicator body to insert an insertion portion of the medical device, which includes an insertion portion configured to be at least partially insertable into the skin, into the skin of the user (e.g., paragraphs [0131]-[0134]: inserter assembly/applicator 200 includes a deployment button 204 and deployment mechanism 208 (shown in Fig. 10) among other elements; Figs. 10-11, inserter unit 208, insertion portion 120/100 extending from needle/sharp carrier 234); an operation portion installed at the applicator body (e.g., Fig. 10, 204, 230) such that at least a part of the operation portion is movable from a deactivated position to an activated position operating the insertion unit (e.g., paragraphs [0132]-[0133]: a deployment mechanism 208 is operable with deployment button 204 and a deployment cap 230, housing body 202 and sensor housing 206 where at least a part of the operation portion moves from a deactivated position (Fig. 10) to an activated or inserted position (Fig. 11)); and a backstop portion configured to lock at least the part of the operation portion in the activated position so as to prevent at least the part of the operation portion from returning from the activated position to the deactivated position (e.g., paragraph [0133]: first catch surface 210 engages a corresponding locking catch 214 when a user presses deployment button 204 into housing body 202 from a ready position (shown in Fig. 10) to an inserted position (shown in Fig. 11); Figs. 10-11, backstop portion 210, 214).
Regarding claim 11, Peterson discloses an applicator assembly comprising:
an applicator body (e.g., paragraph [0132]: inserter assembly 200 incudes a housing body 202; Fig. 9, 202); a medical device including an insertion portion configured to be at least partially insertable in to skin of a user that is capable of being detached from and coupled to the applicator body (e.g., paragraphs [0131]: medical device/continuous monitoring sensor 120 is deployed into skin tissue by driving insertion portion/sharp 100 into the patient’s own tissue; and [0025]: sensor deployment assembly has a needle bore and can be removed from the deployment mechanism); an insertion unit installed at the applicator body to insert the insertion portion into the skin of the user (e.g., paragraphs [0131]-[0134]: inserter assembly/applicator 200 includes a deployment button 204 and deployment mechanism 208 (shown in Fig. 10) among other elements; Figs. 10-11, inserter unit 208, insertion portion 120/100 extending from needle/sharp carrier 234); an operation portion installed at the applicator body so that at least a part of the operation portion is movable from a deactivated position to an activated position operating the insertion unit (e.g., paragraphs [0132]-[0133]: a deployment mechanism 208 is operable with deployment button 204, housing body 2020 and sensor housing 206 where at least a part of the operation portion (button 204) moves from a deactivated position (Fig. 10) to an activated or inserted position (Fig. 11)); and a backstop portion configured to lock at least the part of the operation portion in the activated position so as to prevent at least the part of the operation portion from returning from the activated position to the deactivated position (e.g., paragraph [0133]: first catch surface 210 engages a corresponding locking catch 214 when a user presses deployment button 204 into housing body 202 from a ready position (shown in Fig. 10) to an inserted position (shown in Fig. 11); Figs. 10-11, backstop portion 210, 214).
With respect to claim 2, Peterson discloses the applicator according to claim 1, wherein the backstop portion comprises a backstop detent provided at one of the applicator body and the operation portion (e.g., paragraph [0133]: backstop detent 210 provided at the applicator body 202), and a backstop member provided at an other one of the applicator body and the operation portion so as to be engaged with the backstop detent after the operation portion moves to the activation position (e.g., paragraph [0133]: backstop member 214 provided at the operation portion 204).
As to claim 3, Peterson discloses the applicator according to claim 2, wherein the backstop member comprises a backstop member body provided to be elastically deformable at the other one of the applicator body and the operation portion (e.g., paragraph [0133]: resilient locking catch 214 on deployment button 204 has a resilient length as shown in Figs. 10-11), and a backstop member snap provided at one side of the backstop member body so as to be engaged with the backstop detent (e.g., paragraph [0133] and Figs. 10-11 – the distal end of the locking catch 214 moves outward or snaps to engage the catch surface 210 when moved into the inserted position shown in Fig. 11).
With respect to claim 4, Peterson disclose the applicator according to claim 3, wherein the one of the applicator body and the operation portion is provided with an
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accommodation groove in which at least a portion of the backstop member snap is accommodated when the operation portion is located in the deactivated position (e.g., paragraphs [0030] and [0181]: deployment button 204 is in a ready (deactivated) position where the resilient locking catch 214/ backstop member snap is tensioned inwardly into wall 218 of the applicator body 202 into an accommodation groove – see inset of Fig. 52A).
As to claim 5, as best understood, Peterson discloses the applicator according to claim 1, wherein the operation portion is configured to be movable in a direction that passes or lies/intersects with a direction of movement of the insertion portion by the insertion unit (e.g., Figs. 10-11).
With respect to claim 6, Peterson discloses the applicator according to claim 1, wherein the insertion unit (e.g., Fig. 10, 208) includes a shuttle (e.g., Fig. 10, 231, 234) to which the insertion portion is capable of being detached and coupled, and movably installed at the applicator body to move the insertion portion from a first position where the insertion portion is away from the skin of the user to a second position where the insertion portion is inserted into the skin of the user (e.g., paragraphs [0133]-[0134]: deployment mechanism 208 is slidably received in a cavity of deployment button 204 and includes a needle/sharp carrier with a needle carrier catch 235), and a forward elastic member configured to provide a moving force to the shuttle to move the shuttle to the second position (e.g., paragraph [0133]: one or more springs 216 disposed between deployment button and housing button 202 bias deployment button 204 toward the first or ready position as shown in Fig. 10 – where a force applied by a user moves the shuttle to the activated position), and wherein the operating portion includes a button portion exposed to an outside of the applicator body (e.g., Fig. 10, deployment button 204); and a stopper portion configured to be movable from the deactivated position to the activated position by the button portion (e.g., Figs. 10-11, 235), be engageable with the shuttle in the deactivated position to prevent the shuttle from moving from the first position (e.g., paragraph [0134]), and be disengageable from the shuttle in the activated position to allow the shuttle to move to the second position (e.g., paragraph [0134]: when the user presses deployment button 204, needle carrier catch 235 is released from button catch surface 240 by carrier release surface 203 of housing body 202 and deployment spring 232 – the catch disengages the shuttle so that the shuttle can move to the activated position), and wherein the backstop portion is configured to lock the stopper portion in the activated position (e.g., paragraph [0133]: first catch surface 210 engages a corresponding locking catch 214 when a user presses deployment button 204 into housing body 202 from a ready position (shown in Fig. 10) to an inserted position (shown in Fig. 11); Figs. 10-11, backstop portion 210, 214).
As to claim 8, Peterson discloses the applicator according to claim 1, comprising: a locking hook tiltably coupled to the applicator body to be engaged with the base unit to detachably couple the base unit, attachable to the skin of the user, to the applicator body for the insertion portion to be coupled (e.g., paragraphs [0135]-[0136]: deployment body catch 238 is tiltably coupled to the application body 202 via base catch surface 242 when the deployment button is pushed into the inserted position and can be released to retract the inserted position), wherein the operation portion is configured to restrain movement of the locking hook so that the locking hook is not tilted when at least the part of the operation portion is located in the deactivated position, and release restraint from the locking hook when at least the part of the operation portion is located in the activated position (see Figs. 11-12).
With respect to claim 9, Peterson discloses the applicator according to claim 8, wherein the operation portion includes: a button portion exposed to an outside of the applicator body (e.g., Fig. 10, deployment button 204); a stopper portion configured to move in a direction of intersecting a moving direction of the insertion portion by the button portion (e.g., Figs. 10-11, 235 where the intersecting motion goes from the dashed lines to the solid lines of Fig. 11); and a stopper protrusion extending from the stopper portion toward the locking hook to contact one side of the locking hook and restrain the movement of the locking hook (the angled end of carrier catch 235).
As to claim 10, Peterson discloses the applicator according to claim 1, comprising: a locking body installed at the applicator body to be engaged with at least the part of the operation portion or disengaged from at least the part of the operation portion (e.g., paragraph [0143]: housing body 202 for engagement with deployment button 204 [part of the operation portion] includes a resilient tab that engages sensor housing 206’ via a locking body 206b); and a moving tab linearly movably coupled to the applicator body to move from a locking position, where at least a portion of the moving tab is located inside the applicator body, to a removal position, where at least the portion of the moving tab is drawn outward from the locking body, and wherein the moving tab contacts the locking body at the locking position to deflect the locking body to be engaged with at least the part of the operation portion, and wherein the locking body is disengaged from the operation portion when the moving tab moves to the removal position (e.g., paragraphs [0143]: moving tab 205’ is engages/contacts with locking body 206b where at least a portion of the moving tab is located inside the application body 202 and the moving tab disengages from the operation portion sensor housing 206 at locking body 206b for removal).
Allowable Subject Matter
Claim 7 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
European Patent Application 23 918 944 (cited by Applicant) is directed to an applicator for continuous blood glucose that has an applicator body (100), an insertion unit (300), an operation portion (110) and a backstop portion (114, 1013)(see Figs. 3, 10, and 18) that anticipates claims 1-5 and 8-11. The Examiner notes the publication date of this reference is 08/12/2021.
US Patent Application Publication No. 2017/0231497 to Brister et al. is directed to a transcutaneous analyte sensor having a safety latch mechanism 84 that locks the plunger assembly as illustrated in Fig. 8A is discussed in paragraph [0259], other variations of a safety lock are contemplated.
US Patent Application Publication No. 2007/0173706 to Neinast et al. is directed to a method and apparatus for insertion of a sensor where the operation portion moves horizontally and the insertion portion moves vertically as shown in Fig. 4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792