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 .
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Election/Restriction
Applicant’s election without traverse of Group 1, claims 18-32, in the reply filed on 6/2/2025 is acknowledged. Accordingly, claims 33-37 are withdrawn from consideration.
Response to Amendment
This office action is responsive to the amendment filed on 2/11/2026. As directed by the amendment: claim(s) 18 has been amended. Thus, claims 18-26 and 28-43 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 2/11/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the independent claims on page 7-70:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
“a hollow plunger rod disposed along a longitudinal axis of the syringe support and a compression drive spring disposed within the hollow plunger rod and configured to bias the hollow plunger rod in the distal direction relative to the housing, wherein the hollow plunger rod is configured to move in the distal direction relative to the housing to dispense the medicament from the syringe under an axial force along the longitudinal axis from the compression drive spring.”
Examiner notes that the prior art of Burren is silent regarding the manner that plunger rod 8 is driven linearly to expel the liquid medicament from container 5, see paragraph 22+34.
Examiner's rejection as necessitated by the amendment, below, details the prior art relied upon to teach the limitations of the presently amended claims.
Regarding applicant’s argument regarding dependent claims on page 10:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
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.
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.
Claim 18-20, 24-26, 28-32, 40-41, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over US 20070021718 A1, henceforth written as Burren, in view of US 20090312705 A1, henceforth written as Grunhut.
Regarding Claim 18,
Burren discloses:
An auto-injector comprising:
(paragraph 31-34; injection pen (not enumerated) of the embodiment of fig 4; fig 4
a housing;
(paragraph 31; claimed housing comprises distal housing portion 1 and proximal housing portion 3
a syringe configured to be disposed in the housing, the syringe containing a liquid medicament,
(paragraph 22; medicament container 5, an ampoule, filled with liquid medicament; fig 4)
the syringe having a distal end configured to hold a needle,
(container 5's distal end (not enumerated) is configured to hold a needle in the manner by which it has an outlet suitable for receiving a needle for transferring medicament within container 5 into a patient; see examiner's annotation of Burren's fig 4, below, denoting the outlet on the distal end of container 5)
and the syringe having a proximal end comprising a flange
(see examiner's annotation of Burren's fig 4, below, denoting the flange on the proximal end of container 5)
and a syringe support configured to be disposed in the housing proximal to the syringe and configured to be coupled to the housing,
(paragraph 32; the claimed syringe support comprises spring 20, inclusive of its spring element 21, distal positioning device 24, and proximal positioning device 23; fig 4)
the syringe support having a distal end comprising (i) a flexible portion
(spring element 21; fig 4)
and (ii) a distally-facing surface, wherein the distally-facing surface is configured to engage a proximal surface of the flange of the syringe to bias the syringe in a distal direction relative to the syringe support while the flexible portion at least partially compresses in an axial direction,
(paragraph 30-31; support surface 24a distributes the spring force from spring element 21, thus the partial compression of the claimed flexible portion, uniformly across the proximal surface of container 5; support surface 24a is best viewed in detail as support surface 14a in the embodiment of fig 3)
wherein the syringe support comprises a projecting portion that extends in the axial direction
( fig 4 demonstrates that proximal positioning device 23 extends in an axial direction along the longitudinal axis L)
and the projecting portion comprises an outward protrusion configured to axially couple the syringe support to the housing to limit axial movement of the syringe support relative to the housing,
(paragraph 33; outward protrusion (not enumerated) of positioning device 23 engages the distally facing support surface 23a on housing 3, thus axially couples spring 20 to housing 3 to limit the relative axial movement of spring 20 toward housing 3 and vice versa; see examiner's annotation of Burren's fig 4, below, denoting the outward protrusion of device 23)
a -- plunger rod disposed along a longitudinal axis of the syringe support --
(paragraph 22+34; fig 1 illustrates plunger rod 8 being disposed along the claimed syringe support)
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Burren discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a hollow plunger rod
a compression drive spring disposed within the hollow plunger rod and configured to bias the hollow plunger rod in the distal direction relative to the housing,
wherein the hollow plunger rod is configured to move in the distal direction relative to the housing to dispense the medicament from the syringe under an axial force along the longitudinal axis from the compression drive spring.
However, Grunhut teaches an autoinjector with a hollow plunger rod:
a hollow plunger rod disposed along a longitudinal axis
(paragraph 133; hollow plunger rod 28; fig 18)
a compression drive spring disposed within the hollow plunger rod and configured to bias the hollow plunger rod in the distal direction relative to the housing, wherein the hollow plunger rod is configured to move in the distal direction relative to the housing to dispense the medicament from the syringe under an axial force along the longitudinal axis from the compression drive spring.
(paragraph 106-107+114+119+125-128+133-134; compression drive spring 30 is within and drives the hollow plunger rod 28 linearly to expel medicament, as well as interacting with projections on the inner wall of hollow plunger rod 28 to produce an audible indicator of injection progress for a user)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Grunhet’s teachings of utilizing a compression spring within a hollow plunger rod to propel said plunger rod and trigger user audible indication to the plunger rod disclosed by Burren in order to advantageously arrives at an invention which enables a multitude of different size spring elements to propel the plunger rod, such as those that fit internal to a plunger rod, to provide a injection duration satisfactory for the viscosity of medicament to be distributed, for maximizing comfort of a user, see paragraph 133 of Grunhut, and informing a user of injection progress via an audible indicator, see paragraph 134.
Regarding Claim 19,
Burren in view of Grunhut discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The auto-injector of claim 18, wherein the projecting portion is a first projecting portion, the outward protrusion is a first outward protrusion,
Burren: (the claimed first outward protrusion is considered the outward protrusion engaging support surface 23a, noted in examiner’s annotation of Burren’s fig 4 below)
and the syringe support comprises a second projecting portion that extends in the axial direction, --
Burren: (see examiner’s annotation of Burren’s fig 4, below, denoting the claimed second projecting portion and claimed first projecting portion)
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However, Burren in view of Grunhut is silent regarding:
the second projecting portion comprising a second outward protrusion configured to axially couple the syringe support to the housing to limit axial movement of the syringe support relative to the housing
However, MPEP 2144.04(VI)(B) provides that a modification of the prior amounting to a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Accordingly, duplicating the claimed outward protrusion of Burren such that there are a first and second outward protrusion functionally identically to limit/support a position of spring 20 relative to the housing would similarly lack patentable significance as a new and unexpected result is not produced by such a modification.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the outward protrusion engaging a support surface, respectively on spring 20 and housing 3 of Burren, such that a secondary outward protrusion is disposed on the claimed second projecting portion of Burren in order to advantageously arrive at an invention with redundant means for limiting a relative axial movement/retention of a spring relative to a housing, therein improving the reliability and safety of the invention over its lifetime of repeated use.
Regarding claim 20, the modified device of Burren discloses:
The auto-injector of claim 19, wherein the syringe support has an opening defined by a first surface of the first projecting portion and a second surface of the second projecting portion.
Burren: (claimed opening is defined as the opening within spring 20 which retains linking element 23c, which examiner’s annotation of Burren’s fig 4 in claim 19 above is demonstrated as being between the first and second projection portion)
Regarding claim 24, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the flexible portion comprises a web portion.
Burren: (an interconnected spring member (not enumerated/illustrated) constitutes a web portion of spring 21; see examiner's annotation of Burren's fig 4, below, denoting an interconnected spring member of spring 21 as the web portion of the claimed flexible portion)
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Regarding claim 25, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the syringe support is a unitary structure.
Burren: (fig 4 demonstrates that spring 20 is a unitary structure by the use of the same hatching to illustrate the structure of the syringe support, see MPEP 608.02(v)(3))
Regarding claim 26, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the distally-facing surface has a flat portion configured to engage the proximal surface of the flange.
(see examiner's annotation of Burren's fig 4, above, denoting the distally facing surface of the syringe support as a flat surface which engages the proximal facing of the denoted flange of container 3)
Regarding claim 28, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the outward protrusion is located on a proximal portion of the syringe support.
(see examiner's annotation of Burren's fig 4, above, denoting the outward protrusion of the projecting portion as being location on a proximal portion of spring 20)
Regarding Claim 29,
Burren in view of Grunhut discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The auto-injector of claim 18-- the flexible portion is configured as a spring such that the flexible portion is configured as a resilient spring.
Burren: (flexible spring element 21)
However, Burren in view of Grunhut is silent regarding:
wherein the syringe support is formed from a plastic material and the flexible portion is configured as a spring such that the flexible portion is configured as a resilient plastic spring.
However, an alternative embodiment of Burren provides that its spring, and thus also its its spring element, may easily and cheaply manufactured from a plastic material, see paragraph 6-12+25
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to form the syringe support and flexible portion disclosed by Burren with a plastic material as taught by Burren, in order to advantageously arrive at an invention which can be manufactured from an inexpensive plastic material, see paragraph 10 of Burren.
Regarding claim 30, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the syringe support is axially separated from a syringe carrier of the auto-injector,
Burren: (paragraph 23+29+31; stop 4 is considered to carry container 5 in that it axially supports container 5 and inhibits container 5 from moving axially; fig 4)
and the syringe carrier is configured to retain the syringe when (i) the syringe is disposed within the syringe carrier, (ii) the syringe carrier is disposed within the housing, and (iii) the syringe support is coupled to the housing and disposed within the housing.
Burren: (paragraph 23+29+31; stop 4 can be considered configured to perform the claimed functions in the manner by which it limits an axial movement of container 5 when container 5 is disposed radially within stop 4, while stop 4 is within housing portion 1, and while spring 20 is mated to and disposed within housing portion 3; fig 4)
Regarding claim 31, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the syringe support is configured to be coupled to a proximal portion of the housing.
Burren: (paragraph 33; the outwardly protruding cam 23b mates to a recess (not enumerated/illustrated) on the proximal housing portion 3; fig 4)
Regarding claim 32, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the syringe support is configured to be coupled to the housing via a direct coupling between the outward protrusion and the housing.
Burren: (paragraph 33; spring 20 is considered to be directly coupled to the claimed housing by the manner which the outward protrusion (not enumerated) of device 23 engages the support surface 23a to form a latching/snap fit functional connection between spring 20 and housing 3 thus limiting an axial movement of spring 20 relative to housing portion 3; fig 4)
Regarding claim 40, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the flexible portion is located axially between the distally-facing surface and the projecting portion.
Burren: (fig 4 demonstrates the claimed disposition of spring 21 relative to distal positioning device 24 and proximal positioning device 23)
Regarding claim 41, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein a proximal end of the flexible portion is proximally spaced from the syringe.
Burren: (fig 4 demonstrates the claimed disposition of spring 21 relative to container 5)
Regarding claim 43, Burren in view of Grunhut discloses:
The auto-injector of claim 18, wherein the flexible portion is configured to flex in the axial direction to allow for the auto-injector to accommodate syringes of different lengths.
Burren: (paragraph 3+17+32; spring 21 compensates for the variations in size of container 5 attribute to broad manufacturing tolerances, and thus configured to flex/compress/compensate axially to accommodate different lengths of container 5)
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Burren in view of Grunhut, as applied to claims above, in view of US 20070297845 A1, henceforth written as Gutberlet.
Regarding Claim 21,
Burren in view of Grunhut discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Burren in view of Grunhut is silent regarding the exact shape of its flexible portion such that it is silent regarding:
The auto-injector of claim 18, wherein the flexible portion comprises at least two angled surfaces.
However, Gutberlet teaches a compensating spring support:
wherein the flexible portion comprises at least two angled surfaces.
(paragraph 18-19; See examiner's annotations of Gutberlet's fig 3 and 9, denoting the at least two angled surfaces of the helically shaped spring 23; fig 2-3+8-9; paragraph 47-49 and paragraph 56-59 demonstrating that the spring 23 performs the same core function as Burren’s spring 21 as its spring shape changes to compensate for different axial positions of the elements on either end of the spring)
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Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to substitute the specific three-dimensional helical shape of the compensating spring taught by Gutberlet for the general meandering shape of the compensating spring disclosed by Burren, such that spring 21 of Gutberlet has the claimed shape, because they are equivalent known for the same purpose of biasing elements disposed on either end of a spring, see MPEP 2144.06(II).
Regarding claim 22, the modified device of Burren in view of Gutberlet teaches:
The auto-injector of claim 21, wherein the two angled surfaces have equal and opposite angles with respect to each other and are angled with respect to a longitudinal axis of the housing.
(examiner notes in light of the modification made in claim 21 above, the denoted angled surfaces are demonstrated as being disposed at equivalent and opposing angles relative to each other and relative to the longitudinal axis of the spring/housing of Burren)
Regarding claim 23, the modified device of Burren in view of Gutberlet teaches:
The auto-injector of claim 21, wherein the two angled surfaces define a V-shaped portion.
(examiner notes in light of the modification made in claim 21 above, the denoted angled surfaces form a v shaped portion, as noted in the annotation of Gutberlet’s fig 3 and 9 above)
Claim 38-39 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Burren in view of Grunhut, as applied to claims above, in view of US 20170000955 A1, henceforth written as McLoughlin
Regarding Claim 38,
Burren in view of Grunhut discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Burren in view of Grunhut is silent regarding:
The auto-injector of claim 18, wherein the distally-facing surface comprises one or more protrusions configured to engage the proximal surface of the flange to bias the syringe in the distal direction relative to the syringe support.
However, McLoughlin teaches an autoinjector with means for compensating for variable syringe sizes:
wherein the distally-facing surface comprises one or more protrusions configured to engage the proximal surface of the flange to bias the syringe in the distal direction relative to the syringe support
(paragraph 370-373; biasing and damping element 45 has a plurality of damping projections 47 on its elastomeric, therein flexible, forward part 46, to dampen relative movement between the flange of syringe 10 and cap 60)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement McLoughlin’s teachings of a protruding damping projections 47 disposed on a flexible portion of a syringe support to the flexible portion disclosed by Burren, by disposing McLoughlin’s damping projection 47 on Burren’s distally facing support surface thus combining equivalents known for the same purpose of biasing syringes within an injector, see MPEP 2144.06(I), in order to advantageously arrive at an invention which can protect its medicament container from shocks induced by dropping the invention, see paragraph 370 of McLoughlin.
Regarding claim 39, the modified device of Burren in view of Grunhut and McLoughlin teaches:
The auto-injector of claim 38, wherein the one or more protrusions comprises two or more ribs.
(examiner notes in light of the modification made in claim 38 above, the damping projections 27 of McLoughlin disposed on Burren’s syringe support may be considered ribs, and are demonstrated as having a number in excess of two)
Regarding Claim 42,
Burren in view of Grunhut discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Burren in view of Grunhut is silent regarding:
The auto-injector of claim 18, wherein the syringe comprises a body that extends from (i) a distal end comprising the needle to (ii) a proximal end comprising the flange, and the flange extends radially outward from the body.
However, McLoughlin teaches an autoinjector with means for compensating for variable syringe sizes:
wherein the syringe comprises a body that extends from (i) a distal end comprising the needle to (ii) a proximal end comprising the flange, and the flange extends radially outward from the body
(paragraph 352; syringe 10 has barrel 12, hollow needle 13, and end flange 16 having the claimed shape; fig 2)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to substitute the specific type of syringe taught by McLoughlin for the specific type of syringe disclosed by Burren, in order to advantageously arrive at an invention which can accept and dispense medicament from other types of standard pre filled syringes, see MPEP 2144.06(II), therein improving the versatility of the invention to dispense medicament from other types of prefilled medicament containers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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