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 . Claims 1-20 of the amended claim set received 1/18/2024 are pending.
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 1-4, 8-12, and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards (US 2013/0023822).
Regarding Claim 1, Edwards discloses a needle shield remover assembly for a wearable injector comprising (the injector as shown in Fig. 68 can be worn, e.g. in a clothing pocket or with use of a strap):
a needle shield (Fig. 63) comprising a body 6820 defining an opening 6828 configured to receive a needle of the wearable injector, the body of the needle shield comprising an extension portion 6825 having a top surface (upper surface as shown in the figure) and a bottom surface positioned opposite the top surface; and
a needle shield remover comprising a first portion 6700 (Figs. 60-62) or 6510 (Figs. 65-66) and a second portion (the other of 6700 or 6510), the needle shield remover having an unassembled position (Fig. 71, when the first portion has been removed as shown in Fig. 69) where the first portion is spaced from the second portion and an assembled position (Fig. 68) where the first portion 6700 or 6510 is connected to the second portion (the other of 6700 or 6510), the first portion and the second portion of the needle shield remover defining a needle shield surface (at the end of an element 6722 as shown in Fig. 62) configured to engage the top surface of the extension portion 6825 of the needle shield when the needle shield remover is in the assembled position (as shown in Figs. 62 and 68, read para. 0223).
Regarding Claim 2, Edwards discloses in Fig. 63, wherein the body 6820 of the needle shield has a first end 6821 and a second end 6822 positioned opposite the first end, the opening 6828 of the body positioned at the first end and the extension portion 6825 positioned at the second end.
Regarding Claim 3, Edwards discloses in Fig. 63, the extension portion 6825 comprising a disc-shaped member.
Regarding Claim 4, Edwards discloses in Fig. 63, wherein the extension portion comprises a cylindrical member 6827, with the disc-shaped member 6825 defining the second end of the body 6822 of the needle shield.
Regarding Claim 8, Edwards discloses wherein the first portion of the needle shield 6700 remover is connected to the second portion 6510 of the needle shield remover via a connector 6724 (as shown in Fig. 68).
Regarding Claim 9, Edwards discloses wherein the connector comprises a connector recess 6524 positioned on one of the first portion and the second portion 6510 (see Fig. 65) and a connector member 6724 positioned on the other 6700 of the first portion and the second portion (see Fig. 62).
Regarding Claim 10, Edwards discloses in Fig. 68, wherein the connector recess 6524 and the connector member 6724 form a snap fit connection (along with element 6555 as shown in the figure).
Regarding Claim 11, Edwards discloses in Fig. 66, wherein the second portion 6510 of the needle shield remover comprises a device connector 6534 configured to secure the second portion of the needle shield remover to the wearable injector (as discussed in para. 0231).
Regarding Claim 12, Edwards discloses wherein the first portion 6700 of the needle shield remover comprises a handle 6712 (Fig. 60).
Regarding Claim 15, Edwards discloses a wearable injector comprising:
a housing 6100 (Fig. 22) having a top surface and a bottom surface;
a container 6210 received within the housing 6100 (see Fig. 31), the container configured to receive a medicament (read para. 0143), the container comprising a stopper 6221 configured to move within the container;
a drive assembly 6300 (Fig. 68) configured to move the stopper 6221 (read para. 0250);
a needle 6216 having a retracted position (Fig. 71) where the needle is positioned within the housing 6100 and an extended position (Fig. 73) where a portion of the needle protrudes from the housing; and
a needle shield remover assembly comprising a needle shield (Fig. 63) comprising a body 6820 defining an opening 6828 configured to receive a needle of the wearable injector, the body of the needle shield comprising an extension portion 6825 having a top surface (upper surface as shown in the figure) and a bottom surface positioned opposite the top surface; and
a needle shield remover comprising a first portion 6700 (Figs. 60-62) or 6510 (Figs. 65-66) and a second portion (the other of 6700 or 6510), the needle shield remover having an unassembled position (Fig. 71, when the first portion has been removed as shown in Fig. 69) where the first portion is spaced from the second portion and an assembled position (Fig. 68) where the first portion 6700 or 6510 is connected to the second portion (the other of 6700 or 6510), the first portion and the second portion of the needle shield remover defining a needle shield surface (at the end of an element 6722 as shown in Fig. 62) configured to engage the top surface of the extension portion 6825 of the needle shield when the needle shield remover is in the assembled position (as shown in Figs. 62 and 68, read para. 0223),
wherein the needle shield 6120 receives at least a portion of the needle 6216 (see Fig. 68), and wherein the needle shield remover is in the assembled position (Fig. 68).
Regarding Claim 16, Edwards discloses in Fig. 63, wherein the body 6820 of the needle shield has a first end 6821 and a second end 6822 positioned opposite the first end, the opening 6828 of the body positioned at the first end and the extension portion 6825 positioned at the second end.
Regarding Claim 17, Edwards discloses in Fig. 63, the extension portion 6825 comprising a disc-shaped member.
Regarding Claim 18, Edwards discloses in Fig. 63, wherein the extension portion comprises a cylindrical member 6827, with the disc-shaped member 6825 defining the second end of the body 6822 of the needle shield.
Allowable Subject Matter
Claims 5-7, 13-14, and 19-20 are 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 prior art of record does not disclose or form a reasonable combination teaching the following in combination with the base and intervening claim limitations -
Regarding Claims 5 and 19, “wherein the body of the needle shield comprises a protrusion having a tapered surface and a planar surface, the tapered surface positioned closer to the second end of the body than the planar surface.” It is noted that the EPO dismisses the limitation with the same reference with the reasoning that the limitation is mere design choice, however USPTO practice requires the alternatives to the disclosed design be known. Alternatives to the reference’s needle shield having all the features of claims 2-4 and that of claim 5 or claims 16-18 and claim 19 are not found.
Regarding Claim 13, “wherein the second portion of the needle shield remover comprises a first half moveable relative to a second half, and wherein one of the first half and the second half comprises a cover configured to cover the needle shield after the needle shield remover is connected to the needle shield.”
Claims 6, 7, 14, and 20 are allowable at least by basis on one of the claims discussed above.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found in the attached Notice of References Cited.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE D FORD whose telephone number is (571)272-8140. The examiner can normally be reached on M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached on (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.D.F/Examiner, Art Unit 3741
/PHUTTHIWAT WONGWIAN/Supervisory Patent Examiner, Art Unit 3741
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