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.
Claims 19, 20 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 19 recites “a connector part of a cartridge holder according to claim 1”. Claim 1 recites a cartridge holder having multiple elements including a connector part. It is not clear what the scope of “a connector part of a cartridge holder according to claim 1” because claim 1 includes additional elements, and a claim cannot recite only a part of another claim, rather the claim must include all of the elements of the preceding claim.
Claim 20 inherits the deficiencies of claim 19.
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, 2, 7, 12-14, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klintenstedt et al (US 2017/0312173).
Regarding claim 1, Klintenstedt discloses a cartridge holder 210 for an injection device 240 (figs. 9A 10), the cartridge holder 210 comprising: an elongated body extending in a longitudinal direction (fig. 11), the elongated body comprises a distal end (fig. 11: bottom of page) and a proximal end (fig. 11: top of page) opposite to the distal end, wherein the elongated body confines a cartridge receiving space 214 to accommodate a medicament container 220 (page 4, para. 0054), a retainer part 238 comprising a retainer sidewall confining a distal portion of the cartridge receiving space (fig. 10), the retainer part comprising a proximal end, a connector part 242 comprising a connector sidewall and a distal connector configured to connect to the proximal end of the retainer part (figs. 10, 11; page 4, para. 0059) and comprising a proximal connector 234 configured to connect to a distal end of a device body of the injection device (page 4, para. 0056), wherein the device body is configured to accommodate a drive mechanism to operably engage with the medicament container (fig. 6).
Regarding claim 2, Klintenstedt discloses that the connector sidewall forms a longitudinal extension of the retainer sidewall when the connector part is connected to the retainer part (see fig. 11 annotated below).
PNG
media_image1.png
779
811
media_image1.png
Greyscale
Regarding claim 7, Klintenstedt discloses that the distal connector of the connector part 242 and the proximal end of the retainer part 328 are configured to form at least one of a tension stable and a pressure stable mechanical connection (page 4, para. 0059: friction fit, or alternatively disclosed means are pressure and tension stable).
Regarding claim 12, Klintenstedt discloses that the proximal end comprises a fastening element complementary shaped to a counter fastening element of the distal connector (page 4, para. 0059: locking tabs have complementary shapes).
Regarding claim 13, Klintenstedt discloses that the fastening element and the counter fastening element comprises a recess and a catch element configured to engage with the recess (page 4, para. 0059: locking tabs).
Regarding claim 14, Klintenstedt discloses locking tabs which necessarily include a longitudinally extending tab and a recess.
Regarding claim 16, Klintenstedt discloses that connector part 242 comprises a mechanical coding element 234 to mechanically engage with a complementary shaped mechanical counter coding element 230 of the device body (page 4, para. 0056).
Regarding claim 17, Klintenstedt discloses a medicament container 220 arranged inside the cartridge receiving space (page 4, para. 0054).
Regarding claim 18, Klintenstedt discloses an injection device 240 for setting and injecting of a dose of a medicament (page 4, para. 0054), the injection device comprises: a device body 256, a drive mechanism arranged inside the device body (page 5, para. 0062), wherein the drive mechanism is configured to operably engage with a medicament container 220 containers containing the medicament, and a cartridge holder 210 according to claim 1 (page 5, para. 0062; see claim 1 above) connectable or connected to a distal end of the device body (page 5, para. 0062).
Regarding claim 19, Klintenstedt discloses a container assembly 210 for an injection device, the container assembly 210 comprising: a medicament container 220 comprising a barrel filled with a medicament (page 4, para. 0055), and a connector part 242 of a cartridge holder according to claim 1 (see claim 1 above), wherein the connector part is connected to the medicament container (page 4, para. 0055).
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klintenstedt in view of Elahi et al (US 2010/0042054).
Regarding claim 20, Klintenstedt discloses a container assembly kit comprising: a first container assembly according to claim 19 (see claim 19 above), the first container assembly comprising a first medicament container 220 and a first connector part 242 connected to the first medicament container and comprising a first proximal connector and a first distal connector (fig. 10).
Claim 20 differs from Klintenstedt in calling for a second container assembly, the second container assembly comprising a second medicament container and a second connector part connected or fixed to the second medicament container and comprising a second proximal connector and a second distal connector, wherein the first medicament container distinguishes from the second medicament container and wherein the first proximal connector (59) distinguishes from the second proximal connector. Elahi teaches a kit including a drug delivery device and a second container assembly for receiving a second medicament container, first and second connectors and medical containers distinguish from each other (page 7, para. 0107, 0112) which allows for reuse of the injector with only compatible containers thereby increasing safety of the device and reducing cost of use. 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 device of Klintenstedt to include a second medicament container and container assembly as taught by Elahi so that the injector can be used with only thethe compatibledicaments thereby increasing safety of the device while reducing cost.
Allowable Subject Matter
Claims 3-6, 8-11, 15 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 claims listed below cannot be found and was not suggested by the prior art of record.
Regarding claim 3, the subject matter not found is the connector sidewall and the retainer sidewall flush in the longitudinal direction, in combination with the features of the invention, substantially as claimed.
Regarding claim4, the subject matter not found is an inside surface of the connector sidewall flush with an inside surface of the retainer sidewall and/or wherein an outside surface of the connector sidewall with an outside surface of the retainer sidewall, in combination with the features of the invention, substantially as claimed.
Regarding claim 5, the subject matter not found is the connector part comprising a flange portion extending radially inwardly from the connector sidewall, the flange portion comprising a distally facing stop face configured to abut with a proximal end of the medicament container, in combination with the features of the invention, substantially as claimed.
Regarding claim, the subject matter not found is the proximal end of the retainer part comprising a proximal end face complementary shaped to a distal end face of the connector part and wherein the proximal end face is in longitudinal abutment with the distal end face when the connector part is connected to the retainer part, in combination with the features of the invention, substantially as claimed.
Regarding claim 8, the subject matter not found is the connector part comprises a container fastener configured to mechanically engage with a proximal end of the medicament container, in combination with the features of the invention, substantially as claimed.
Regarding claim 15, the subject matter not found is the distal connector comprises a predetermined breaking structure, which is configured to break apart the distal connector when a user attempts to disengage the distal connector from the proximal end of the retainer part, 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.
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, 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.
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.
LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
Prosecution Insights