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 Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1, lines 8-9 recites “a user- wearable infusion pump on a body of a user” and should recite “the user- wearable infusion pump on the body of the user”.
In claim 5, line 2, there should be a comma after the word “housing”.
Appropriate correction is required.
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 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 15 and 16 recite “at least one arm”. It is unclear if this refers to the “one or more arms” recited in base claim 13 or additional arms. Clarification is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Gray et al. (US 2018/0368774).
Regarding claim 1, Gray discloses an applicator device (Figure 5) for inserting a holder for a user-wearable infusion pump (paragraph 446 describes the holder having an insulin delivery device) onto a body of a user (Figure 1 shows the body of a user), comprising:
a housing (Figure 5, 160);
a fluid path module (paragraph 30 describes a fluid path) including a cannula (paragraph 30) disposed within the housing (paragraph 446);
a drive wheel (Figure 5, 514) disposed within the housing (Figure 5);
an actuation mechanism (Figure 5, 510) configured to selectively cause the drive wheel to be actuated (paragraph 188); and
a tray release mechanism (Figure 5, 508) configured to releasably retain (paragraph 196) a tray (Figure 5, 524) configured to hold a user-wearable infusion pump on a body of a user (Figure 5),
wherein actuation of the drive wheel causes the drive wheel to rotate to insert the cannula into the user's skin (paragraph 196 describes the drive wheel 514 moving the needle carrier assembly 508 into the body, and thus the needle in the needle carrier assembly and paragraph 8 describes this even clearer) and to release the tray from the tray release mechanism for application onto the user's skin (paragraph 196).
Regarding claim 2, Gray discloses wherein a single actuation of the actuation mechanism causes both the cannula to be inserted into the user's skin and the tray release mechanism to release the tray (paragraph 196 describes the rotation of the drive wheel causes the needle carrier assembly 508, and thus the cannula, into the skin and releases the tray 524 from the tray release mechanism 508).
Regarding claim 3, Gray discloses further comprising a cover (Figure 5, 502 and 504) disposed around and movable with respect to the housing and wherein the actuation mechanism includes a button (505, see paragraph 185) extending through the cover.
Regarding claim 4, Gray discloses further comprising a safety mechanism (paragraph 338 describes a safety mechanism) that prevents actuation of the button from actuating the drive wheel when the safety mechanism is engaged (paragraph 338).
Regarding claim 5, Gray discloses wherein when the cover (Figures 71-73C, 7101) is in an upright position with respect to the housing (Figure 73A shows the cover 7101 is in an upright position with respect to the housing as shown by 7102) the safety mechanism prevents actuation of the button and if the cover is held down against the housing the safety mechanism is disengaged such that actuation of the button is enabled (paragraph 338).
Regarding claim 6, Gray discloses wherein the cover is biased to the upright position with respect to the housing prior to actuation of the drive wheel (Figure 73A shows this, paragraph 354).
Regarding claim 7, Gray discloses wherein following actuation of the drive wheel the cover is configured to remain held down against the housing (paragraph 358).
Regarding claim 8, Gray discloses wherein the tray release mechanism comprises one or more pins (Annotated figure 5) configured to be releasably inserted through one or more corresponding apertures in the tray (Annotated figure 5 and figures 7A-7C shows the pin in the corresponding aperture).
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Regarding claim 9, Gray discloses wherein the drive wheel is actuated by a pre-wound torsion spring (paragraph 11).
Regarding claim 10, Gray discloses the applicator device of claim 1, configured as a one-time use device configured to be disposed of after a single actuation of the drive wheel (This is intended use, the applicator device is structurally capable of being used for a single actuation and disposed of afterward).
Regarding claim 11, Gray discloses an ambulatory infusion pump system (Figure 5), comprising:
a tray (Figure 5, 524) configured to hold a user-wearable infusion pump (paragraph 446 describes the holder having an insulin delivery device);
an adhesive patch (Figure 2B, 226) configured to adhere the tray to a body of a user (Figure 1 shows the body of a user); and
an applicator device (Figure 5, 500) for attaching the tray onto the body of the user, the applicator device comprising –
a housing (Figure 5, 160);
a fluid path module (paragraph 30 describes a fluid path) including a cannula (paragraph 30) disposed wit fdsa4h\in the housing (paragraph 446);
a drive wheel (Figure 5, 514) disposed within the housing (Figure 5);
an actuation mechanism (Figure 5, 510) configured to selectively cause the drive wheel to be actuated (paragraph 188); and
a tray release mechanism (Figure 5, 508) configured to releasably retain (paragraph 196) the tray (Figure 5, 524),
wherein actuation of the drive wheel causes the drive wheel to rotate to insert the cannula into the user's skin (paragraph 196 describes the drive wheel 514 moving the needle carrier assembly 508 into the body, and thus the needle in the needle carrier assembly and paragraph 8 describes this even clearer) and to release the tray from the tray release mechanism for application onto the user's skin (paragraph 196).
Regarding claim 12, Gray discloses wherein a single actuation of the actuation mechanism causes both the cannula to be inserted into the user's skin and the tray release mechanism to release the tray (paragraph 196 describes the rotation of the drive wheel causes the needle carrier assembly 508, and thus the cannula, into the skin and releases the tray 524 from the tray release mechanism 508).
Regarding claim 13, Gray discloses wherein the tray release mechanism comprises one or more arms (Annotated figure 5, labeled pin) configured to be releasably inserted through one or more corresponding slots in the tray (Annotated figure 5, labeled aperture, and figures 7A-7C shows the arm in the corresponding slot).
Regarding claim 14, Gray discloses wherein rotation of the drive wheel causes the one or more arms to disengage from the one or more corresponding slots to release the tray from the applicator device (Figures 7A-7F shows that turning the drive wheel 514 moves the arm out of the slot, see annotated figure 7F).
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Regarding claim 15, Gray discloses wherein at least one arm slides linearly out of a corresponding slot (Figures 7A-7F show the arm slides linearly out of the slot).
Regarding claim 16, Gray discloses wherein at least one arm flexes to disengage from a corresponding slot (Intended use, when the arm bears against the slot, such as if they are slightly misaligned, the arm with flex as it disengages from the slot).
Regarding claim 17, Gray discloses wherein the fluid path module (paragraph 30 describes a fluid path) comprises a body (the fluid path module necessarily has a body to contain the fluid and figure 33A shows the body through which the cannula 3274 extends) having the cannula extending therefrom (paragraph 30).
Regarding claim 18, Gray discloses wherein actuation of the drive wheel causes the body of the fluid path module to be seated within a corresponding opening in the tray (Figure 33A, tray 508 is shown as 3224 in figure 33A).
Regarding claim 19, Gray discloses wherein the fluid path module and the opening include corresponding features configured to lock the fluid path module within the opening (Figure 33A shows the opening in the fluid path module and the opening in the tray each have springs which hold the module in the desired orientation within the opening).
Regarding claim 20, Gray discloses further comprising a user-wearable infusion pump (paragraph 446 describes the holder having an insulin delivery device) configured to be releasably retained by the tray (Figure 5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katheryn Malatek whose telephone number is (571)272-5689. The examiner can normally be reached Monday - Thursday, 9 am - 6 pm.
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/KATHERYN A MALATEK/Primary Examiner, Art Unit 3741
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