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 .
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 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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims are objected to because of the following informalities:
Cl.1 “and retraction collar” is believed to be in error for –and the retraction collar—
Cl.8: “springe” is believed to be in error for –spring—
Cl.21: “and proximal end” is believed to be in error for –and a proximal end--
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.
Claims 1-22 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 pre-AIA the applicant regards as the invention.
Regarding Claims 1 and 21, the recitation(s) “a syringe” renders the claim indefinite because it is unclear whether the syringe is referring to, or includes previously claimed syringe components (such as medicament container, plunger, and plunger rod), or whether all the syringe components must be mutually exclusive with the previously claimed elements.
Regarding claim 13, “the distal end of the device” lacks antecedent basis in the claims.
Regarding claim 15, “the at least one engagement element” lacks antecedent basis in the claims.
Dependent Claims 2-20 and 22 are also rejected for relying on at least one rejected claim above.
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.
(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.
Claim(s) 1-3, 5, 9, 11-13, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first interpretation of Henley 20140323979 (hereinafter Henley1).
Regarding claim 1, Henley1 teaches an injection device (Figs 3A-B), comprising:
a housing (2.1, 2.2 and/or 22) defining a longitudinal axis (centered therewithin);
a drive spring (15) disposed within the housing (portion 2.2), the drive spring having a distal end and a proximal end opposite the distal end along the longitudinal axis (following the proximal-distal convention of Henley1), and the drive spring defining an interior cavity (radially therewithin);
a plunger (5) disposed at least partially within a medicament container (3);
a plunger rod (10) engaged with the plunger (Figs 3A-B); and
a drive-lock mechanism (incl. 11, 11.3, 10.1) comprising:
a latch mechanism (incl.11) at least partially received within the interior cavity and comprising at least one engagement portion (11.3) configured to releasably engage the plunger rod (Figs 10A-B versus 11A-B), wherein the latch mechanism is configured to move distally under action of the drive spring (per Figs 6A-9B); and
a retraction collar (10.1) engaged with the latch mechanism,
wherein the latch mechanism is configured to move from a drive-locked position (per any of Figs 3A-10B) to a drive-unlocked position relative to the retraction collar (Figs 11A-11B),
wherein, in the drive-locked position, the retraction collar holds the at least one engagement portion in engagement with the plunger rod such that extension of the drive spring moves the latch mechanism and retraction collar distally to expel medicament from a syringe (Figs 3A-9B), and
wherein, in the drive-unlocked position, the retraction collar does not hold the at least one engagement portion in engagement with the plunger rod, thus permitting the at least one engagement portion to disengage the plunger (Fig 11A-B; 10.1 releases 11.3 from engagement with 10).
Regarding claim 2, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches the latch mechanism (further including at least distal wall of 22 and 11.1; in this case, the housing is only considered to be 2.2, 2.1 and not including 22) comprises a distal flange (distal wall of 22) in contact with the distal end of the drive spring (Figs 3A-B).
Regarding claim 3, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches the latch mechanism and the retraction collar are configured to move distally in tandem when the latch mechanism is in the drive-locked position (Figs 6A-8B).
Regarding claim 5, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches that in the drive-locked position, the latch mechanism is configured to move distally with the retraction collar due to frictional engagement between the latch mechanism and the retraction collar (there is friction between 11.3 and 10.1 during engagement).
Regarding claim 9, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches the latch mechanism comprises a latch extension (22) configured to engage with the drive spring and a latch (11.1) engaged with the latch extension (Figs 3A-9B).
Regarding claim 11, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches the latch mechanism has a monolithic body (11 and 11.3 formed together).
Regarding claim 12, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches a handle (in this case, the housing is 22, and the handle is 2.2), wherein the housing is axially movable relative to the handle from an inactive position (5A-B) to an active position (6A-9B), wherein movement of the housing from the inactive position to the active position releases the drive spring from a compressed condition (spring expanding only when housing moves relative to handle).
Regarding claim 13, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches the movement of the housing from the inactive position to the active position upon compression of the distal end of the device against injectable tissue is configured to release the drive spring from the compressed condition (device must be pressed against tissue at 16, which moves 23 to unlock button 21, which is used to activate the housing from the active position to the inactive position and allow the spring to expand).
Regarding claim 18, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches the retraction collar comprises a sleeve (10.1 comprising arms arranged annularly to form a sleeve) including at least one opening (central opening to receive 11.3).
Regarding claim 20, Henley1 teaches all the limitations of the claimed invention as discussed above. Henley1 further teaches the drive spring defines a single spring (15) configured to 1) move the syringe axially through the housing (Figs 6A-7B; syringe translates axially to puncture tissue), and 2) expel the medicament from the syringe (Figs 7A-9B).
Claim(s) 1, 5, 7-10, 15, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a second interpretation of Henley (hereinafter Henley2).
Regarding claim 1, Henley2 teaches an injection device (Figs 3A-B), comprising:
a housing (2.1, 2.2) defining a longitudinal axis (centered therewithin);
a drive spring (15) disposed within the housing (portion 2.2), the drive spring having a distal end and a proximal end opposite the distal end along the longitudinal axis (following the proximal-distal convention of Henley2), and the drive spring defining an interior cavity (radially therewithin);
a plunger (5) disposed at least partially within a medicament container (3);
a plunger rod (11) engaged with the plunger (Figs 3A-B); and
a drive-lock mechanism (incl. 22, 11.1) comprising:
a latch mechanism (incl.22) at least partially received within the interior cavity (22 comprises at least one radially inner wall that is within the interior cavity) and comprising at least one engagement portion (at least central aperture in distal wall of 22) configured to releasably engage the plunger rod (Figs 7A-8B versus 10A-B), wherein the latch mechanism is configured to move distally under action of the drive spring (per Figs 6A-9B); and
a retraction collar (11.1) engaged with the latch mechanism,
wherein the latch mechanism is configured to move from a drive-locked position (per any of Figs 3A-8B) to a drive-unlocked position relative to the retraction collar (Figs 10A-10B),
wherein, in the drive-locked position, the retraction collar holds the at least one engagement portion in engagement with the plunger rod such that extension of the drive spring moves the latch mechanism and retraction collar distally to expel medicament from a syringe (Figs 3A-9B), and
wherein, in the drive-unlocked position, the retraction collar does not hold the at least one engagement portion in engagement with the plunger rod, thus permitting the at least one engagement portion to disengage the plunger (Fig 10A-B; 11.1 releases 22 from engagement with 11).
Regarding claim 5, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches that in the drive-locked position, the latch mechanism is configured to move distally with the retraction collar due to frictional engagement between the latch mechanism and the retraction collar (there is friction between 11.1 and 22 during engagement).
Regarding claim 6, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches the latch mechanism is configured to move from the drive-locked position to the drive-unlocked position by overcoming friction between the latch mechanism and the retraction collar due to force applied by the drive spring (drive spring is required to push 11.1 into 24 in order to disengage 22 from 11; 11.1 being in contact with 22 during the disengagement, the combined forces to disengage must overcome at least the friction force between 22 and 11.1).
Regarding claim 7, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches the latch mechanism is configured to retain the drive spring in a compressed condition prior to activation of the injection device (21.1 holds 22 via 22.1, in a spring-compressed position per Fig 5A, until activation per Figs 6A and 7A).
Regarding claim 8, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches the latch mechanism defines at least one engagement element (22.1) configured to be releasably secured to a portion (21.1 of 21 of 2.2) of the housing to retain the drive springe in the compressed condition (Fig 5A).
Regarding claim 9, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches the latch mechanism comprises a latch extension (axially extending walls of 22) configured to engage with the drive spring and a latch (distal wall of 22) engaged with the latch extension (formed therewith).
Regarding claim 10, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches the latch comprises the at least one engagement portion (Fig 5A) and the latch extension comprises at least one engagement element (22.1).
Regarding claim 15, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches the at least one engagement element (22.1) is secured between the housing (2.2) and an actuator (21) in the inactive position (Fig 5A).
Regarding claim 21, Henley2 teaches a method of manufacturing an autoinjector (Figs 3A-B), comprising:
providing a housing (2.1, 2.2) defining a longitudinal axis (centered therewith);
disposing a drive spring (15) within the housing, the drive spring having a distal end and proximal end opposite the distal end along the longitudinal axis (following naming convention of Henley2), the drive spring defining an interior cavity (radially therewithin);
disposing a plunger (5) at least partially within a medicament container (3);
engaging a plunger rod (11) with the plunger (Figs 3A-B);
engaging a latch mechanism (incl.22) with a retraction collar (11.1) to form a drive-lock mechanism (Figs 3A-5B), the latch mechanism comprising at least one engagement portion (at least central aperture in distal wall of 22);
disposing the latch mechanism at least partially within the interior cavity (22 comprises at least one radially inner wall that is within the interior cavity) and releasably engaging the at least one engagement portion with the plunger rod (Figs 7A-8B versus 10A-B); and
arranging the retraction collar in a drive-locked position (Figs 3A-9B) such that the retraction collar holds the at least one engagement portion in engagement with the plunger rod and extension of the drive spring moves the latch mechanism and retraction collar distally (Figs 3A-9B) to expel medicament from a syringe (incl. 3, 4),
wherein the retraction collar is configured to move from the drive-locked position to a drive-unlocked position (Figs 10A-B) wherein the retraction collar does not hold the at least one engagement portion in engagement with the plunger rod (11.1 releases 22 from engagement with 11).
Regarding claim 22, Henley2 teaches all the limitations of the claimed invention as discussed above. Henley2 further teaches compressing the distal and proximal ends of the drive spring into a compressed condition (Figs 3A-5B); and
configuring the latch mechanism to retain the drive spring in the compressed condition (Figs 3A-5B).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached on (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741