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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 23, 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2-6, 10, and 14 are objected to because of the following informalities:
Claims 2-6 depend from Claim 1, which defines “a contact surface provided on each pair of sidewalls” in line 12. This means that there are two contact surfaces on the motor body, and thus two corresponding surfaces on the cassette body. These multiple contact surfaces should be reflected in claims 2-6, by saying “each contact surface of the motor body” and “each corresponding contact surface of the cassette body”.
In Claim 10, line 1, “the protrusion” should likely read “the at least one protrusion”, as Claim 10 depends from claim 8, which defines “at least one protrusion”.
In Claim 14, “contact between” is likely missing prior to “the at least one protrusion” in line 1.
In Claim 14, line 2, “is” should read “are”, as the term is referring to a plurality.
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 7 and 14 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 7 recites the limitation "the at least contact surface of the motor body is provided on an inside face of the sidewall of the motor body" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be treated as “the at least one contact surface” in its place. However, the motor body in claim 1 recites a “pair of sidewalls” (line 11) with “a contact surface provided on each of the pair of sidewalls” (line 12). This means that at least two contact surfaces of the motor body, as well as two sidewalls, are present in the invention, which renders “at least one contact surface” and “the sidewall” as indefinite terms. The examiner recommends amending “the at least contact surface of the motor body is provided on an inside face of the sidewall of the motor body” to “each contact surface of the motor body is provided on an inside face of the corresponding sidewall of the motor body”.
Claim 14 recites “the at least one protrusion and the contact surface of the motor body is provided on opposite sides of the sidewall of the motor body”. Claim 14 is dependent on Claim 1, which defines the motor body as having a “pair of sidewalls” (line 11) with “a contact surface provided on each of the pair of sidewalls” (line 12). This means that at least two contact surfaces of the motor body, as well as two sidewalls, are present in the invention, which renders “the contact surface” and “the sidewall” as indefinite terms. Furthermore, it is unclear whether “opposite sides of the sidewall” is referring to the same sidewall or the pair that is referred to in Claim 1. Furthermore, it is unclear what “opposite” is relative to, since more than one sidewall is mentioned.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
Claim(s) 1-6, 8-10, 12, and 14-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Besson et al. (US 2022/0111152 A1).
Regarding claim 1, Besson et al. discloses a drug delivery device comprising
an upper housing shell (upper housing shell 46 in Fig. 3);
a lower housing shell (lower housing shell 28 in Fig. 3);
a syringe (syringe assembly 16 in Fig. 2A) comprising a barrel (barrel 52 in Fig. 2A), a stopper (stopper 54 in Fig. 2A), and a needle (cannula 56 in Fig. 2A), at least a portion of the syringe positioned within the lower housing shell (Paragraph [0083]);
a drive assembly (drive assembly 40 in Fig. 2A) comprising a plunger body (plunger body 80 in Fig. 2A) configured to move the stopper within the barrel upon actuation of the drive assembly (Paragraph [0085]);
a cassette body (cassette body 314 in Fig. 37) configured to receive the syringe (Paragraph [0108]); and
a motor body (motor body 302 in Fig. 25) configured to engage the cassette body (Paragraph [0102]),
wherein the motor body comprises:
a pair of sidewalls (reinforcing rib(s) 326 in Fig. 25, Paragraph [0102]: the reinforcing rib(s) 326 provide additional support for the pair of arms 260 of the motor body 302); and
a contact surface provided on each of the pair of sidewalls (cassette clip(s) 328 in Fig. 25), the contact surface engaging a corresponding contact surface of the cassette body (see below).
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Regarding claim 2, Besson et al. discloses the drug delivery device of claim 1, and further discloses that the contact surface of the motor body comprises a planar, substantially vertical surface (planar face 334 in Fig. 26).
Regarding claim 3, Besson et al. discloses the drug delivery device of claim 1, and further discloses that the corresponding contact surface of the cassette body comprises a planar, substantially vertical surface (see figure above).
Regarding claim 4, Besson et al. discloses the drug delivery device of claim 1, and further discloses that the contact surface of the motor body continuously contacts the corresponding contact surface of the cassette body along a length of the contact surface of the motor body (Paragraph [0102] explains how the motor body and cassette body are secured to each other through the cassette clip(s), see below).
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Regarding claim 5, Besson et al. discloses the drug delivery device of claim 1, and further discloses that the cassette body comprises at least one motor body rib (motor body rib(s) 368 in Fig. 38) comprising the contact surface of the cassette body.
Regarding claim 6, Besson et al. discloses the drug delivery device of claim 5, and further discloses that the contact surface of the cassette body extends substantially the entire length of the at least one motor body rib (see below).
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Regarding claim 8, Besson et al. discloses the drug delivery device of claim 1, and further discloses that the motor body comprises at least one protrusion configured to engage a corresponding wall surface of the cassette body (see below).
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Regarding claim 9, Besson et al. discloses the drug delivery device of claim 8, and further discloses that the cassette body comprises a pair of sidewalls comprising the corresponding wall surface (see below).
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Regarding claim 10, Besson et al. discloses the drug delivery device of claim 8, and further discloses that the protrusion comprises a curved outer surface (see below).
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Regarding claim 12, Besson et al. discloses the drug delivery device of claim 8, and further discloses that contact between the at least one protrusion and the corresponding wall surface of the cassette body defines a predetermined distance between inside faces of the sidewalls of the motor body (see below). The distance, D, between the sidewalls of the motor body is shown. Since there is no mention of movement in positioning of the sidewalls, and movement would be unpredictable, one would find it reasonable to predict D to be the distance between the sidewalls upon manufacture of the motor body.
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Regarding claim 14, Besson et al. discloses the drug delivery device of claim 8, and further discloses that the at least one protrusion and the contact surface of the motor body are provided on opposite sides of the sidewall of the motor body (see below).
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Regarding claim 15, Besson et al. discloses the drug delivery device of claim 8, and further discloses that the at least one protrusion is provided on an outside face of the sidewall of the motor body (see below). Both labeled protrusions may be considered as outside relative to the rest of the sidewall.
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Allowable Subject Matter
Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 11 and 13 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The document (KR20210132144A) was publicly available prior to the 102(a)(1) date of the reference relied upon in the 102(a)(1) rejection detailed above, and contains all of the same limitations relied upon in the rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AIDAN L NATHAN whose telephone number is (571) 270-0798. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AIDAN L NATHAN/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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