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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 24, 2026 has been entered.
Claim Objections
Claims 36 and 37 are objected to because of the following informalities: claims 36 and 37 depend on canceled claim 35, these claims are considered to depend on claim 19. 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.
Claim 34 is 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 34 recites “a medicament container” “a medicament container” is now recited in claim 19. It is not clear if these are the same or different containers. For purposes of the rejection they are taken to be the same.
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.
Claim(s) 19-34, 36, 37 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brereton et al. (US 2013/0289492 A1).
With regard to claim 19, Brereton et al. teach a drug delivery device comprising: a housing with a housing element fixed to or integrated in the housing, wherein the housing is configured to hold a medicament container axially fixed to the housing (Fig. 1 the housing element is 2 and the housing is 8 which are fixed [0062], [0083] after use the device is locked and container 5 is axially fixed to 8, see Figs. 10 and 19, 8 surrounds 4 which surrounds 5); a protection member arranged axially movable with respect to the housing element and configured to cover a drug delivery element (Fig. 1 member 3); and a movable member received in the housing and circumferentially surrounded by the housing element, wherein the movable member is arranged axially and rotationally movable with respect to the housing element and arranged rotationally movable with respect to the protection member (Fig. 1 member 12, [0067], see at least Fig. 19 members 8 and 2 surround 12), wherein the drug delivery device has an initial state in which (i) the protection member is in an extended position to cover the drug delivery element (Fig. 1) (ii) the protection member is movable in a proximal direction from the extended position into a retracted position to expose the drug delivery element (see at least Fig. 8, [0065]) and (iii) the protection member is coupled to the movable member in a distal direction and the proximal direction ([0064] 12 and 3 are rigidly connected) such that (a) a distal movement of the protection member in the distal direction results in a distal movement of the movable member (see at least [0064], Figs. 13 and 16) and (b) a proximal movement of the protection member results in a proximal movement of the movable member (see at least [0065], Fig. 4), wherein the drug delivery device is configured such that, starting from the initial state, a movement of the protection member in the proximal direction initiates a rotation of the movable member relative to the protection member by a predetermined angle (see at least [0067], [0075]), whereby the coupling of the protection member and the movable member in the distal direction is released such that the protection member is movable towards the extended position relative to the movable member (see at least [0079]), wherein the movable member is configured to be rotated during movement of the protection member in the proximal direction (the device as whole may be rotated and moved proximally, alternatively while the protection member is moved proximally to a retracted position the device may be rotated which would rotate the movable member).
With regard to claim 20, see Fig. 1 plunger rod 9, energy member 7, and lock interface between 10.2 and 9.4. See at least [0061], [0070], [0074] regarding states and movement.
With regard to claim 21, see Fig. 1 transfer member 10 which rotates to allow release of the plunger ([0070]).
With regard to claims 22 and 23, see at least the movement of member 10 in the L shaped aperture shown in Fig. 9.
With regard to claim 24, 7 is connected to 2 at 2.5 and is connected to 10 via the connection to 8 at 8.1; 10 and 8 are connected.
With regard to claims 25-28, member 4 is also considered as part of the housing element which is keyed to 3, 12.3 (protrusion) provides a first rotation lock feature and 3.3/3.35/4.2 (slit) provides a lock feature of the housing element to lock 12 and 4 via 3 ([0058], [0063], [0064], [0067]). 10 is connected to 12 via 4, second rotation lock feature 12.4 engages a rotation-lock surface of 4 providing a rotation-lock feature of 10 ([0064], [0067]). A slide is formed by the thread 4.1 (thread would have a beveled surface), as 12 rotates relative to 4 12.3 slides along the thread ([0067], [0068]).
With regard to claim 29, 12 moves axially relative to 2, see transition in the Figs.
With regard to claims 30-32, see protection coupling feature 3.3 and moveable member coupling feature 12.3 which can be considered to have sections (Fig. 5, [0063], [0067]).
With regard to claim 33, a coupling surface of 12 abuts coupling 2.3 of the housing element (exemplary Fig. 7, [0068]).
With regard to claim 34, container 5, needle 6 (Fig. 1, Fig. 6, see 3 move with respect to 8 in transition between Fig. 12-Fig. 13).
With regard to claims 36 and 37, see container 5 and needle 6 (Fig. 1, Fig. 6, abstract).
With regard to claim 39, Brereton et al. teach a drug delivery device comprising: a housing element (Fig. 10 members 10.2); a housing with the housing element axially fixed to the housing (Fig. 1 member 10 axially fixed to 10.2); a medicament container holder configured to hold a medicament container, wherein the medicament container holder is axially fixed with respect to the housing (Fig. 1 member 4, [0063]); a protection member arranged axially movable with respect to the housing element and configured to cover a drug delivery element (Fig. 1 member 3, [0070]); and a movable member arranged axially and rotationally movable with respect to the housing element and arranged rotationally movable with respect to the protection member (Fig. 1 member 12, [0067], exemplary movement in Figs. 6-8), wherein the drug delivery device has an initial state in which (i) the protection member is in an extended position to cover the drug delivery element (Fig. 1) (ii) the protection member is movable in a proximal direction from the extended position into a retracted position to expose the drug delivery element (see at least Fig. 8, [0065]) and (iii) the protection member is coupled to the movable member in a distal direction and the proximal direction ([0064] 12 and 3 are rigidly connected) such that (a) a distal movement of the protection member in the distal direction results in a distal movement of the movable member (see at least [0064], Figs. 13 and 16) and (b) a proximal movement of the protection member results in a proximal movement of the movable member (see at least [0065], Fig. 4), wherein the drug delivery device is configured such that, starting from the initial state, a movement of the protection member in the proximal direction initiates a rotation of the movable member relative to the protection member by a predetermined angle (see at least [0067], [0075]), whereby the coupling of the protection member and the movable member in the distal direction is released such that the protection member is movable towards the extended position relative to the movable member (see at least [0079]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Different features of Brereton are relied upon in light of the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
