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 § 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.
Claim 10, 11 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 10 recites the limitation "the pump engine" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 inherits the deficiencies of claim 10.
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.
Claim(s) 1-7, 10, 11, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mojarrad et al (US 2020/0164155).
Regarding claim 1, Mojarrad discloses a drug delivery device, comprising a delivery unit including a drug container 200 comprising a barrel portion 270 and a plunger 244 slidably mounted within the barrel portion and sealing the drug within the container at one end of the barrel portion (fig. 5B; page 4, para. 0053), and a drive unit 250 comprising a pneumatic flow system 240 and a pneumatic pumping system 250 configured to pump air via the pneumatic flow system to a space behind the plunger to generate a gas pressure to advance the plunger in the container during drug delivery (fig. 5B; page 4, para. 0053), wherein the drug delivery device comprises a sealing adaptor 246 mounted on an end of the drug container facing an outer side of the plunger (fig. 5B), the sealing adaptor comprising a sealing plug inserted inside an end of the barrel portion (fig. 5B; page 4, para. 0054), the sealing plug comprising an orifice 246a configured for pluggable sealing connection to a gas channel connector (distal portion of 256 received in channel 246a) of the pneumatic flow system (fig. 5b; page 4, para. 0054).
Regarding claim 2, Mojarrad discloses that the gas channel connector comprises a tubular end portion pluggably inserted in the orifice of the sealing plug (fig. 5b).
Regarding claim 3, Mojarrad discloses that the sealing plug comprises an inner radial sealing ring comprising a portion extending axially from an end wall of the sealing plug, said orifice for sealing connection to the gas channel connector being formed within the inner radial sealing ring (see fig. 5B annotated below).
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Regarding claim 4, Mojarrad discloses that the plunger comprises a back end forming a cavity (fig. 6), said axial extension of the inner radial sealing ring being positioned at least partially in the cavity in an initial position prior to drug delivery (fig. 6: portion 248 forming part of the axial extension is at least partially received in the cavity).
Regarding claim 5, Mojarrad discloses that the sealing plug comprises an outer radial sealing ring 246b comprising a portion extending axially from an end wall of the sealing plug, the outer radial sealing ring sealingly engaging an inner surface of the barrel portion of the drug container (fig. 5B; page 4, para. 0054).
Regarding claim 6, Mojarrad discloses that the sealing adaptor comprises a cap inserted over an end of the barrel portion (see fig. 7 annotated below), the cap comprising an end wall engaging a back end of the sealing plug and one or more locking members engaging a housing component of the delivery unit in which the drug container is received (see fig. 7 annotated below).
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Regarding claim 7, The drug delivery device according to claim 6, wherein the housing component of the delivery unit is a container casing within which the drug container is inserted in the delivery unit, the locking member of the sealing adaptor cap engaging the complementary locking member on the container casing.
Regarding claim 10, Mojarrad discloses that the pneumatic flow system comprises a channel housing 250 component within which a gas channel 256 is formed extending between the gas channel connector and the outlet of the pump engine (fig. 5B).
Regarding claim 11, Mojarrad discloses that the gas channel housing component is formed as a separated part assembled in the drive unit to the pump engine (fig. 5B shows all separate assembled components).
Regarding claim 13, Mojarrad discloses that the drug container is a drug cartridge 242’ and comprises a septum 214’ at one end (fig. 7).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mojarrad in view of Wyssman (US 5,741,275).
Claim 8 calls for the one or more locking members on the cap comprises one or more elastic latches having a locking shoulder engaging a complementary locking shoulder on the outside of the container casing. Mojarrad shows locking members as discussed above with regard to claim 6, but fails to disclose that they are elastic. Wyssman teaches a cap 1159 having elastic latches with a locking shoulder for engaging a complementary locking shoulder on the outside of the container casing to provide a secure connection that is easy to assembly (col. 6, lines 55-61; fig. 12a). it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap of Mojarrad to include one or more elastic latches as taught by Wyssman to allow for easy connection of the cap to the device and provide secure connection thereto.
Allowable Subject Matter
Claims 9, 12, 14 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 subject matter of the listed claims could not be found in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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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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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783