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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19, 20, 22, 29, 31-35, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al (US 2013/0218095).
Regarding claim 19, Butler discloses:
A drug delivery device (Fig. 1A) comprising: a mechanism unit (Figs. 4-5) comprising an electrical element (¶0143 – the embodiment being relied on is a mechanical dose selection, which is controlled by a locking arrangement activated by a solenoid) and an arrangement (300) for changing an operational state of the mechanism unit (¶0132); wherein the mechanism unit is configured to (a) enable a dispense process for dispensing a drug (¶0119 – drug delivery device).
Although the locking mechanism of Figs. 4 and 5 describes a mechanical lock (¶0135), Butler also teaches that the mechanical system can use an electro-mechanical lock (¶0143) and therefore incorporates an interaction with the electrical element (e.g. a solenoid) of the system. The detailed lock mechanism allows a selected drug reservoir unit (¶0135 – a matching coded cartridge 120) to couple with the mechanism unit (Fig. 4) to change the configuration of the lock (300), where only the presence of a compatible reservoir (120) allows the lock to change configuration (¶0135). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention that the electro-mechanical lock of ¶0143 could be used with the lock system of Figs. 4-5 such that the change in lock configuration is related to a change in a characteristic manner of the electrical element in order to provide an electro-mechanical lock as disclosed by Butler.
Regarding claim 20, Butler discloses:
The drug delivery device of claim 19, wherein a change of the operational state is associated with a mechanical change in the mechanism unit (see rejection of claim 19 above); and wherein the change of the operational state is a change between a state where at least one of setting of a drug dose or dispensing of a drug dose is prevented (¶0135 – dose setting is prevented before unlocking the lock) and a state where the at least one of setting of the drug dose or dispensing of the drug dose is enabled (¶0135 – dose setting is allowed after unlocking the lock).
Regarding claim 22, Butler discloses:
The drug delivery device of claim 19, wherein the arrangement comprises an electromechanical actuator (¶0143); and wherein operation of the arrangement for changing the operational state comprises operation of the electromechanical actuator (¶0143).
Regarding claim 29, Butler discloses:
The drug delivery device of claim 19, wherein the mechanism unit (Fig. 4) comprises a guiding structure (308) for interacting with a guide structure (302) of a drug reservoir unit (¶0135); and wherein when coupling the drug reservoir unit (120) with the mechanism unit, an interaction between the guiding structure (308) and the guide structure (302) fixes a position of the drug reservoir unit relative to the electrical element (¶0135 – the coupling of the reservoir results in fixing the reservoir with respect to the device, which is fixed with respect to the electrical element).
Regarding claim 31, Butler discloses:
The drug delivery device of claim 19, comprising a drug reservoir unit (120), the drug reservoir unit (120) comprising at least one of a drug reservoir filled with a drug (¶0113) or a drug reservoir holder, and a coupling element (¶0121); wherein when the drug reservoir unit (120) is coupled with the mechanism unit (Fig. 4), the coupling element (¶0121) changes the electrical property of the electrical element in a characteristic manner (see rejection of claim 19 above).
Regarding claim 32, Butler discloses:
The drug delivery device of claim 19, comprising a drug reservoir unit (120) comprising a drug reservoir (¶0113).
Regarding claim 33, Butler discloses:
The drug delivery device of claim 32, wherein the drug reservoir comprises a drug (¶0115).
Regarding claim 34, Butler discloses:
A drug reservoir unit (120; Fig. 1A) for a drug delivery device (Fig. 1A), the drug reservoir unit comprising: at least one of a drug reservoir filled with a drug (¶0113) or a drug reservoir holder; a coupling element (¶0121).
Although the locking mechanism of Figs. 4 and 5 describes a mechanical lock (¶0135), Butler also teaches that the mechanical system can use an electro-mechanical lock (¶0143) and therefore incorporates an interaction with the electrical element (e.g. a solenoid) of the system. The detailed lock mechanism allows a selected drug reservoir unit (¶0135 – a matching coded cartridge 120) to couple with the mechanism unit (Fig. 4) to change the configuration of the lock (300), where only the presence of a compatible reservoir (120) allows the lock to change configuration (¶0135). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention that the electro-mechanical lock of ¶0143 could be used with the lock system of Figs. 4-5 such that the change in lock configuration is related to a change in a characteristic manner of the electrical element in order to provide an electro-mechanical lock as disclosed by Butler.
Regarding claim 35, Butler discloses:
A drug delivery device (Fig. 1A) comprising: a mechanism unit (Figs. 4-5) comprising an electrical element (¶0143 – the embodiment being relied on is a mechanical dose selection, which is controlled by a locking arrangement activated by a solenoid) and an arrangement (300) for changing an operational state of the mechanism unit (¶0132); wherein the mechanism unit is configured to (a) enable a dispense process for dispensing a drug (¶0119 – drug delivery device), and operatively couple with a selected drug reservoir unit (120; ¶0135)
Although the locking mechanism of Figs. 4 and 5 describes a mechanical lock that unlocks when interacting with a compatible coded reservoir (¶0135), Butler also teaches that the mechanical system can use an electro-mechanical lock (¶0143) and therefore incorporates an interaction with the electrical element (e.g. a solenoid) of the system. The detailed lock mechanism allows a selected drug reservoir unit (¶0135 – a matching coded cartridge 120) to couple with the mechanism unit (Fig. 4) to change the configuration of the lock (300), where only the presence of a compatible reservoir (120) allows the lock to change configuration (¶0135). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention that the electro-mechanical switch of ¶0143 could be used with the lock system of Figs. 4-5 such that the change in lock configuration is related to a change in a characteristic manner of the electrical element in order to provide an electro-mechanical lock as disclosed by Butler.
Regarding claim 37, Butler discloses:
The drug delivery device of claim 35, wherein the mechanism unit (Fig. 4) comprises a guiding structure (308) for interacting with a guide structure (302) of a drug reservoir unit (¶0135) so that when coupling the drug reservoir unit (120) with the mechanism unit, a position of the drug reservoir unit (120) relative to the electrical element is fixed by an interaction between the guiding structure (308) and the guide structure (302) (¶0135 – the coupling of the reservoir results in fixing the reservoir with respect to the device, which is fixed with respect to the electrical element).
Regarding claim 38, Butler discloses:
A method of delivering a medicament from a drug delivery device (Fig. 1A), the method comprising: providing a drug delivery device (Fig. 1A) with a mechanism unit (Figs. 4-5) comprising an electrical element (¶0143 – the embodiment being relied on is a mechanical dose selection, which is controlled by a locking arrangement activated by a solenoid) and a dispense mechanism for dispensing a drug dose (¶0115); coupling the drug delivery device (Fig. 1A) with a drug reservoir unit (120), the drug reservoir unit comprising a drug reservoir comprising a drug (¶0113); and dispensing a drug dose by moving at least one element of the dispense mechanism relative to another element of the dispense mechanism (¶0115).
Although the locking mechanism of Figs. 4 and 5 describes a mechanical lock (¶0135), Butler also teaches that the mechanical system can use an electro-mechanical lock (¶0143) and therefore incorporates an interaction with the electrical element (e.g. a solenoid) of the system. The detailed lock mechanism allows a selected drug reservoir unit (¶0135 – a matching coded cartridge 120) to couple with the mechanism unit (Fig. 4) to change the configuration of the lock (300), where only the presence of a compatible reservoir (120) allows the lock to change configuration (¶0135) and allow dose setting and therefore dose dispensing. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention that the electro-mechanical lock of ¶0143 could be used with the lock system of Figs. 4-5 such that the change in lock configuration is related to a change in a characteristic manner of the electrical element in order to provide an electro-mechanical lock as disclosed by Butler.
Allowable Subject Matter
Claims 21, 23-28, 30, and 36 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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.
/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
Prosecution Insights