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 .
Response to Arguments
Applicant's arguments filed on 07/17/2025 have been fully considered.
Applicant’s arguments with respect to claim(s) 1-18 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.
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 15 and 18 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 15 recites the limitation “dispensing a drug through the syringe upon actuating the injection activation button after unlocking the lock”. It is unclear what order this limitation is disclosing, whether the lock is unlocked first, then the injection activation button is actuated or if the injection activation button is actuated first, then the lock is unlocked. For examining purposes, the examiner will be interpreting this limitation as the injection activation button is actuated first, then the lock is unlocked.
Claim 18 recites the limitation "the needle" in line 10. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the examiner will be interpreting “the needle” in line 10, as “a needle”.
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.
Claims 1-2, 4-9, 11-16, and 18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hautaviita et al. (US Pub No. 20180008773 A1, herein, Hautaviita).
Regarding claim 1, Hautaviita discloses a drug delivery device comprising:
a housing (10 – Fig.1) including a proximal end (14 – Fig.1) and a distal end (12 – Fig.1);
a needle guard (30 – Fig.1) disposed at the proximal end of the housing (Fig.1) and movable in an axial direction relative the housing between a first position and a second position (Para [0032]);
a storage container (18 – Fig.1) disposed within the housing (Fig.2) for storing a drug and including a needle (24 – Fig.2) for administering the drug (“the medicament container has a proximal end on which a medicament delivery member, FIG. 2, is arranged” – Para [0031]);
an injection activation button (100 -Fig.4, Para [0078]) disposed on the distal end of the housing (Fig.4) and including a fingerprint detector (162 – Fig.4); and
a lock (“a locking mechanism” – Para [0041]) configured to switch between a locked configuration inhibiting actuation of the drug delivery device and an unlocked configuration enabling actuation of the drug delivery device (Para [0048]), wherein actuation of the drug delivery device includes exposing the needle outside of the needle guard at the proximal end of the housing for administration (“exposing the medicament delivery member such that a penetration is performed when the medicament delivery member is an injection needle” – Para [0032]), the lock being in the unlocked configuration when the fingerprint detector detects a fingerprint (“The identification module then compares the read fingerprint with pre-stored fingerprints from the user, and if there is a match, the medicament delivery device is unlocked” – Para [0078]).
Regarding claim 2, Hautaviita discloses the drug delivery device as set forth above, wherein the fingerprint detector is mounted on the distal end of the injection activation button (Fig.4).
Regarding claim 4, Hautaviita discloses the drug delivery device as set forth above, further including a controller (“The circuit of the identification module is then arranged with processor” – Para [0056]) coupled to the fingerprint detector (“the identification module may comprise a suitable keying circuit” – Para [0054]) and the lock (“identification module may be connectable to specific medicament delivery devices such that the specific medicament delivery devices are unlocked and activated” – Para [0054]).
Regarding claim 5, Hautaviita discloses the drug delivery device as set forth above, wherein the controller is programmed to determine if a fingerprint or thumb print is detected and, if a fingerprint or thumb print is detected, place the lock in the unlocked configuration (“he/she places a finger on the sensor, or swipes the finger over the sensor, whereby the fingerprint is read” – Para [0078], “compares the read fingerprint with pre-stored fingerprints from the user, and if there is a match, the medicament delivery device is unlocked” – Para [0078]).
Regarding claim 6, Hautaviita discloses the drug delivery device as set forth above, wherein,
when the needle guard (30 – Fig.1) is in the first position, the needle guard is partially disposed outside the proximal end of the housing; and
when the needle guard is in the second position, the needle guard is substantially or entirely disposed within the proximal end of the housing (Para [0032], “the medicament delivery member guard is moved inside and relative the housing when the medicament delivery device is pressed against a dose delivery site” – Para [0038]).
Regarding claim 7, Hautaviita discloses the drug delivery device as set forth above, further including a removable needle cap configured to protect the needle (“protective cap that will keep medicament delivery members sterile, which protective cap has to be removed before use” – Para [0084]).
Regarding claim 8, Hautaviita discloses the drug delivery device as set forth above, further including:
a plunger (64 – Fig.3) disposed in the container for storing a drug (Para [0040]); and
a biasing member (68 – Fig.3) configured to translate linearly within the housing when the lock is in the unlocked configuration (Para [0040], Para [0062]).
Regarding claim 9, Hautaviita discloses the drug delivery device as set forth above, wherein the biasing member is also configured to push the plunger toward the proximal end of the housing such that a drug is dispelled from the drug storage container and through the syringe (Para [0040]).
Regarding claim 11, Hautaviita discloses the drug delivery device as set forth above, wherein the drug delivery device provides user feedback when the injection activation button is actuated while the lock is in the locked configuration (Para [0041], Para [0042], Para [0088]).
Regarding claim 12, Hautaviita discloses a method of operating a drug delivery device, comprising:
providing a drug delivery device including a housing (10 – Fig.1), a syringe (18, 24 – Fig.2), a needle guard (30 – Fig.1), an injection activation button (100 -Fig.4) having a fingerprint detector (162 – Fig.4), and a lock (“a locking mechanism” – Para [0041]);
unlocking the lock of the drug delivery device via placing a thumb or a finger on the fingerprint detector on the injection activation button (“compares the read fingerprint with pre-stored fingerprints from the user, and if there is a match, the medicament delivery device is unlocked” – Para [0078]);
causing the needle to become exposed outside of the needle guard after unlocking the lock (“exposing the medicament delivery member” – Para [0032]); and
actuating the injection activation button with the thumb or finger (“when a user is to activate the medicament delivery device, he/she places a finger on the sensor” - Para [0078]).
Regarding claim 13, Hautaviita discloses the method of operating a drug delivery device as set forth above, further comprising depressing the needle guard, causing the needle guard to move axially into the housing (Para [0032], “the medicament delivery member guard is moved inside and relative the housing when the medicament delivery device is pressed against a dose delivery site” – Para [0038]).
Regarding claim 14, Hautaviita discloses the method of operating a drug delivery device as set forth above, further including removing a needle cap from the needle guard before depressing the needle guard (“protective cap that will keep medicament delivery members sterile, which protective cap has to be removed before use” – Para [0084]).
Regarding claim 15, Hautaviita discloses the method of operating a drug delivery device as set forth above, further comprising dispensing a drug through the syringe upon actuating the injection activation button after unlocking the lock (“compares the read fingerprint with pre-stored fingerprints from the user, and if there is a match, the medicament delivery device is unlocked” – Para [0078], Para [0040]).
Regarding claim 16, Hautaviita discloses the method of operating a drug delivery device as set forth above, further including alerting a user if the injection activation button is actuated before unlocking the lock (Para [0041] - [0042], Para [0088]).
Regarding claim 18, Hautaviita discloses a method of preparing a drug delivery device, comprising:
providing a drug delivery device including a housing (10 – Fig.1), a syringe (18, 24 – Fig.2), a needle guard (30 – Fig.1), an injection activation button (100 -Fig.4) having a fingerprint detector (162 – Fig.4), and a lock (“a locking mechanism” – Para [0041]);
positioning the needle guard of the drug delivery device against a surface (“the medicament delivery device is pressed against a dose delivery site” – Para [0032]);
placing a finger or thumb on the fingerprint detector (“places a finger on the sensor” – Para [0078]);
transitioning the lock from a locked configuration to an unlocked configuration in response to detecting the finger or thumb placed on the fingerprint detector (“compares the read fingerprint with pre-stored fingerprints from the user, and if there is a match, the medicament delivery device is unlocked” – Para [0078]); and
causing a needle (24 – Fig.3) to become exposed outside of the needle guard after transitioning the lock to the unlocked configuration (“exposing the medicament delivery member” – Para [0032]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hautaviita in view of Day et al. (US Pub No. 20130221097 A1, herein, Day).
Regarding claim 3, Hautaviita discloses the drug delivery device as set forth above, but Hautaviita does not expressly disclose wherein the fingerprint detector is one of an optical scanner, a capacitive or complementary metal oxide semiconductor (CMOS) scanner, an ultrasound scanner, or a thermal scanner.
Day teaches a drug delivery device (100 – Fig.1A) wherein a fingerprint detector (204 – Fig.2, “fingerprint-recognition technology” – Para [0137]) is one of a capacitive (“capacitive sensor” – Para [0137]) or complementary metal oxide semiconductor (CMOS) scanner.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the fingerprint detector of Hautaviita to be one of a capacitive scanner as taught by Day since Day teaches a capacitive scanner is a well known scanner for a fingerprint detector (Day, Para [0137]).
Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hautaviita in view of Arefieg (US Pub No. 20140243635 A1).
Regarding claim 10, Hautaviita discloses the drug delivery device as set forth above, but Hautaviita does not expressly disclose wherein the lock is a solenoid latch member.
Arefieg teaches a drug delivery device (10 – Fig.1) comprising a lock that is a solenoid latch member (“A latch solenoid” – Para [0036]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the lock of Hautaviita to be a solenoid latch member as taught by Arefieg since Arefieg teaches that a solenoid latch is a well-known latch lock.
Regarding claim 17, Hautaviita discloses the method of operating a drug delivery device as set forth above, but Hautaviita does not expressly disclose wherein unlocking the lock comprises retracting a solenoid latch.
Arefieg teaches unlocking a lock comprises retracting (“release the latch” – Para [0036]) a solenoid latch (“latch solenoid” – Para [0036]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the lock of Hautaviita to be a solenoid latch member as taught by Arefieg since Arefieg teaches that a solenoid latch is a well-known latch lock.
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 Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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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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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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