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.
Claim Objections
Claim 10 is objected to because of the following informalities: refers to “the rear end flange of the syringe” which lacks appropriate antecedent basis as no rear end flange of the syringe had been previously recited in the present or preceding claim. 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 1-20 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.
Regarding claim 1
There is a lack of antecedent basis for “the syringe” in the claims as only an “automatic syringe” had been previously recited in the preamble of the claim, rendering the claim unclear as to whether it is referring to the automatic syringe or is instead referring to a pre-filled syringe which is a component/element of the greater automatic syringe. For examination purposes “the syringe” is to be interpreted as a distinct element from the automatic syringe in view of paragraph 88 and fig 1 of applicant’s disclosure.
Regarding claim 2-20
Claims 2-20 are at least rejected for being dependent upon the rejected independent claim 1.
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) 1-8 and 10-20 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by WO 2013016832 A1, henceforth written as Kaufmann.
Regarding claim 1, Kaufmann discloses:
An automatic syringe, comprising:
(injection device (not enumerated) of fig 26-36)
a housing;
(housing 470; fig 26)
a needle guard cover;
(needle guard 410; fig 26)
a push rod;
(drive means 450; fig 26)
a prompting cylinder;
(end clicker 490; fig 27)
an inner tube;
(control sleeve 480; fig 26-27)
a release ring;
(rotary sleeve 440; fig 27)
a driving elastic member; and
(drive means 460, a helical spring and therein elastic; fig 26)
a resetting elastic member;
(needle guard spring 420, and therein elastic; fig 26)
wherein a syringe fixing structure for fixing the syringe is arranged in the housing;
(syringe holder 430; fig 26)
an opening for a needle to extend out is arranged at a front end of the housing;
(fig 30 illustrates the opening (not enumerated) which needle 495 may extend from)
the release ring and the needle guard cover are sequentially and slidably arranged on an inner side of the housing from a rear end to the front end of the housing;
(fig 27-29, page 13 paragraph 4, and page 15 paragraph 2-3 demonstrate the sequential and slidable arrangement of the rotary sleeve 440 and needle guard 410 within housing 470)
the needle guard cover is configured to extend out of the front end of the housing and slide towards the rear end relative to the housing to push the release ring;
(fig 27-29 and 31-36 demonstrate the extension and rearward sliding functionality of needle guard 410 to displace sleeve 440)
the resetting elastic member is configured to act on the release ring and drive the release ring to push the needle guard cover to slide towards the front end of the housing;
(page 15 paragraph 2 and page 16 paragraph 5; needle guard spring 420 biases rotary sleeve 440 to bias needle guard 410 into the needle protection position; fig 31-36)
the housing is provided with a needle-guard-cover limiting structure for limiting a forward sliding distance of the needle guard cover relative to the housing;
(stop 415 on needle guard 410, therein provided with housing 470, prevents needle guard 410 from falling out of the injection device; fig 26)
the push rod is slidable in the housing along an axial direction; a front end of the push rod is configured to push a piston in the syringe; the driving elastic member is configured to act on the push rod and drive the push rod to slide towards a front end of the syringe;
(page 15 paragraph 4; drive means 460 acts on drive means 450 to slide and consequently push piston 450a)
a push-rod limiting structure is arranged on an outer circumference of the push rod;
(page 13 paragraph 4 through page 14 paragraph 2; support surface 452 on an outer circumference of drive means 450; fig 26)
the prompting cylinder is slidably sleeved on the outer circumference of the push rod along the axial direction;
(page 13 paragraph 4 through page 14 paragraph 2 and page 16 paragraph 2-3; end clicker 490 is slidably sleeved on drive means 450 to provide audible feedback to a user, informing them of injection progress and therein can be considered prompting, and further may considered a cylinder by its central axially extended cylindrical post between its cam arms 491; fig 26)
the driving elastic member is configured to act on the prompting cylinder and drive the prompting cylinder to slide towards a rear end of the housing;
(page 16 paragraph 3; drive means 460 biases end clicker 490 relative to sleeve 480 and housing 470 until clicker 490 abuts housing 470; fig 26+31-32)
the prompting cylinder is provided with a push-rod-limiting cooperating structure;
(page 16 paragraph 2-3; cam arms 491; fig 26+31-32)
a prompting-cylinder limiting structure is arranged between the prompting cylinder and the inner tube;
(page 14 paragraph 2-3; retention slots of sleeve 480 for receiving cam arms 491 of end clicker 490, therein between sleeve 480 and clicker 490; fig 26)
the inner tube is fixed inside the housing and sleeved on an outer circumference of the prompting cylinder;
(control sleeve 480 sleeved on an outer circumference of end clicker 490; fig 26-28)
the release ring is slidably sleeved on an outer circumference of the inner tube;
(rotary sleeve 440 sleeved on an outer circumference of control sleeve 480; fig 26-28)
the inner tube is provided with a first clip capable of elastically moving along a radial direction, and the first clip is deviated radially outward under its own elastic force; and
(page 15 paragraph 3 through page 16 paragraph 1 and fig 27-28-31-32 demonstrate that inner trip cam 480c are tensioned radially outward until biased by drive means 460 to disengage from support surface 452)
the first clip is configured to be deviated radially inward under limiting from an inner wall of the release ring, and be snap-fitted and position-limited with the push-rod limiting structure through the push-rod-limiting cooperating structure;
(fig 27-28 demonstrate the radial inward flexing on inner trip cam 480c by the radially inner surface of rotary sleeve 440, and fig 29+31 demonstrate the cam 480c being flexed or snapped into the support surface 452 to limits its radial deflection)
under support of an outer wall of the push rod, the prompting-cylinder limiting structure is configured to limit sliding of the prompting cylinder relative to the inner tube; and
(page 14 paragraph 2; cam arms 491 within retention slots on control sleeve 480 are prevented from radial inward deflection by an outer surface of drive means 450, and consequently prevented from displacing proximally, therein limiting slide of end clicker 490 relative to control sleeve 480; fig 28 )
after the push rod has slid towards the front end for a preset distance, the prompting-cylinder limiting structure is no longer supported by the push rod.
(page 16 paragraph 2-3 and fig 31-32 demonstrate that after drive device 450 reaches a certain axial position, end clicker 490 is permitted to travel proximally relative to control sleeve 480, and thus releasing the support of control sleeve 480's retention slots via drive device 450)
Regarding claim 2, Kaufmann discloses:
The automatic syringe according to claim 1, wherein a signal structure is arranged at the rear end of the housing and configured to collide and be position-limited with the prompting cylinder.
(page 16 paragraph 3; the proximal end surface (not enumerated) of end clicker 490 is stopped by, therein collides with, the distal inner surface (not enumerated) of sleeve 480, adjacent the rear end of housing 470, to produce a clicking sound indicating a signal to the user that the active ingredient has been dispensed; fig 28+32; see examiner's annotation of Kaufmann's fig 28 below denoting the claimed signal structure)
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Regarding claim 3, Kaufmann discloses:
The automatic syringe according to claim 2, wherein the signal structure is an end plate fixed at the rear end of the housing.
(distal inner surface (not enumerated) of sleeve 480 may be considered an end plate fixed at the rear end of housing 470 in the manner by which its radial outward ledge engages the rear facing wall of housing 470; fig 28+32)
Regarding claim 4, Kaufmann discloses:
The automatic syringe according to claim 1, further comprising a needle cap detachably connected to a front end of the needle guard cover.
(cap 400 detachable from guard 410; fig 26-30)
Regarding claim 5, Kaufmann discloses:
The automatic syringe according to claim 4, wherein a rear end of the needle cap is provided with a claw for catching a rear end of a needle sheath, and the claw is configured to exert a pulling force on the needle sheath towards the front end.
( page 13 paragraph 4; claw 402 engages protection cap 401 to facilitate removal of cap 401 when cap 400 is removed; fig 26-30)
Regarding claim 6, Kaufmann discloses:
The automatic syringe according to claim 4, wherein an anti-dropping recess-protrusion engaging structure is arranged between an inner ring of the needle cap and a circumference of the needle guard cover.
(See examiner's annotation of Kaufmann's fig 27 denoting the anti-dropping recess-protrusion engaging structure between the inner circumferential surface of cap 400 and a circumferential surface of guard 410)
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Regarding claim 7, Kaufmann discloses:
The automatic syringe according to claim 4, wherein a needle-cap limiting structure is arranged between the housing and the needle cap, wherein the needle-cap limiting structure is configured to limit a movement of the needle cap towards the rear end relative to the housing.
(retaining ring 435 of housing 470 engage claws 402 to hold them radially inward to engage cap 401, such that claws 402 and thus cap 400 is limited from displacing proximally relative to housing 470; fig 27-28 demonstrate that disposition of ring 435 between housing 470 and cap 400)
Regarding claim 8, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the syringe fixing structure is a syringe fixing cylinder fixed on the inner side of the housing,
(fig 26-28 demonstrate holder 430 as having a cylindrical shape and being fixed radially within housing 470)
and a front end of the syringe fixing cylinder is provided with a syringe clamping claw for position-limiting and cooperating with a front shoulder of the syringe.
(page 14 paragraph 4 and fig 27-28 demonstrate that a distal shoulder (not enumerated) of drug container 110 is engaged by shoulder 234, therein the syringe clamping claw, to retain container 110 within holder 430)
Regarding claim 10, Kaufmann discloses:
The automatic syringe according to claim 1, wherein a front end of the inner tube abuts against a rear end face of the rear end flange of the syringe, and a rear end of the inner tube abuts against the rear end of the housing.
(balance spring 31 on a distal end of control sleeve 480 abuts a proximal face of the distal flange of drug container 110, and the proximal end of sleeve 480 abuts the proximal end of housing 470; fig 26+28-32)
Regarding claim 11, Kaufmann discloses:
The automatic syringe according to claim 10, wherein the rear end of the housing is provided with an annular protrusion coaxially cooperating with the rear end of the inner tube; and
(see examiner's annotation of Kaufmann's fig 28 denoting the ring shaped proximal face of housing 470 which may be considered the annular protrusion which coaxially cooperates with the radial outward ledge of sleeve 480)
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a rotation limiting structure for preventing the inner tube from rotating is arranged between a side wall of the housing and the inner tube.
(page 14 paragraph 3; while cam 481 of sleeve 480 is disposed in mounting slot 471 of housing 470, therein between a side wall of housing 470 and the sleeve 480, the sleeve is prevented from rotation relative to housing 470; fig 26-28+32)
Regarding claim 12, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the push-rod-limiting cooperating structure is a prompting-cylinder avoidance notch defined in a side wall of the prompting cylinder, and the prompting-cylinder avoidance notch extends along an axial direction of the prompting cylinder.
(see examiner's annotation of Kaufman's fig 28, in particular providing a simplified representation of Kaufman's prompting cylinder, clicker 490, to denote the prompting-cylinder avoidance notch defined in a side wall of the prompting cylinder as being disposed in the space in-between cam arms 490)
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Regarding claim 13, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the prompting-cylinder limiting structure comprises a prompting-cylinder protrusion arranged on an outer wall of the prompting cylinder and an inner-tube clamping hole defined in the inner tube for clamping and limiting the prompting-cylinder protrusion.
(page 14 paragraph 2-3; retention slots of sleeve 480 receiving cam arms 491 of end clicker 490 to limit proximal movement of end clicker 490, thus the retention slots can be considered the claimed inner tube clamping hole by the manner by which it secures/clamps the axially extending leg, the claimed prompting cylinder protrusion, of cam arms 491 to inhibit proximal displacement and relative rotation of end clicker 490; fig 26-28 and examiner's annotation of Kaufman's fig 26+28)
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Regarding claim 14, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the inner tube is provided with an inner-tube avoidance slot hole extending along the axial direction,
(see examiner's annotation of Kaufman's fig 26 denoting the aspect of control sleeve 480 which is considered the claimed inner tube avoidance slot hole, this opening of control sleeve 480 may be considered the inner tube avoidance slot hole in the manner by which it permits passage, therein an avoidance slot hole, of a tubular structure inside of the opening)
wherein the release ring is provided with a second clip which is in sliding fit with the inner-tube avoidance slot hole and configured to interact with the prompting cylinder,
(The gap 453, in particular it's proximal facing surface noted in examiner's annotation of fig 26, may be considered a second clip configured to interact with the prompting cylinder by the manner by which its interaction with end clicker 490 permits the radial inward flexion of cam arms 491; fig 32; further the proximal facing surface of gap 453 can be considered to be provided with rotary sleeve 440 in the manner by which the proximal facing surface of gap 453 are provided with each other rotary sleeve 400 as components of the entire injection device.)
and an outer side of the prompting cylinder is provided with a clip limiting structure used for limiting a movement of the second clip towards the rear end of the housing.
(the distal facing surface of the end clicker, noted in examiner's annotation of fig 26, may be considered the claimed clip limiting structure impeding the rearward movement of the proximal facing surface of gap 453 in the manner by which it provides a surface for drive means 460 to bias end clicker 490 away from drive means 450, and thus providing a surface for the proximal facing surface of gap 453 to be biased away from and limiting its rearward movement.
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Regarding claim 15, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the push rod is of a hollow rod-shaped structure, and the driving elastic member is a push rod spring arranged inside the push rod, wherein the push rod spring is compressed between a front end of the push rod and a rear end of the prompting cylinder.
(fig 27-29 illustrate the hollow nature of drive means 450 retaining drive means 460 for drive means 460 to be compressed between drive means 450 and a distal facing surface of end clicker 490)
Regarding claim 16, Kaufmann discloses:
The automatic syringe according to claim 15, wherein a spring guide rod is slidably arranged in the push rod, and the push rod spring is sleeved on an outer circumference of the spring guide rod.
(fig 26-29 and 31-32 illustrate that the central axially extending post of end clicker 490 receives drive means 460 as a sleeve around its outer circumference)
Regarding claim 17, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the resetting elastic member is a reset spring compressed between the release ring and the housing.
(fig 29+31-32 illustrates that when needle guard spring 420 is compressed, it disposed radially between rotary sleeve 440 and housing 470)
Regarding claim 18, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the housing comprises a front housing and a rear housing, wherein the front housing is connected to a front end of the rear housing.
(housing 470 can be considered to comprise a front housing defined by the distal portion of housing 470 proximate the window in housing 470, and also comprise a rear housing defined by the proximal portion housing 470 proximal of the window in housing 470; see examiner's annotation of Kaufmann's fig 26; the noted front housing can be considered connected to the front end of the rear housing in the manner by which they are demonstrated as integrally formed, therein connected, together)
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Regarding claim 19, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the housing and the needle guard cover are each provided with an observation window extending along the axial direction.
(see examiner's annotation of Kaufmann's fig 26 denoting the observation window of housing 470 and needle guard 410)
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Regarding claim 20, Kaufmann discloses:
The automatic syringe according to claim 1, wherein the needle-guard-cover limiting structure comprises a first limiting step arranged on an inner wall of the housing
(fig 28 demonstrates that the stop 415, therein the first limiting step of the needle-guard-cover limiting structure , is sliding against an inner wall of housing 470, therein arranged on the inner wall of housing 470)
and a second limiting step arranged on an outer wall of the needle guard cover.
(stop 432 disposed on the outer wall of guard 410 engages stop 415 to limit the position of needle guard 410; fig 26+28)
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kaufmann, as applied to claims above, in view of US 20130184655 A1, henceforth written as Lanzi.
Regarding Claim 9,
Kaufmann 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 automatic syringe according to claim 8, wherein a rear end of the syringe fixing cylinder is provided with a support body for position-limiting and cooperating with a rear end flange of the syringe,
(proximal facing surface (not enumerated) of holder 320 may considered the claimed support body in the manner by which its position limits a distal position/movement of drug container 110 by interacting with the distal facing surface (not enumerated) of drug container 110, therein the rear end flange of the claimed syringe; see examiner's annotation of Kaufmann's fig 29+36 denoting the claimed support body and claimed rear end flange)
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However, Kaufmann is silent regarding:
an elastic cushion block is arranged between the support body and a front end face of the rear end flange of the syringe
However, Lanzi teaches a support for a pre-filled syringe in a syringe holder in an autoinjector comprising:
an elastic cushion block is arranged between the support body and a front end face of the rear end flange of the syringe
(paragraph 27-33+69; the elastomeric pad 50 is disposed between a distal face of flange 16 and the bearing seat 38 of the syringe support 36 in order to compensate for slack manufacturing tolerances of the syringe 12 and further inhibit rotation of syringe 12 relative to support 36; fig 1-4)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Lanzi’s teachings of disposing an elastomeric pad between a syringe holder and syringe flange to the support body and rear end flange disclosed by Kaufmann, in order to advantageously arrive at an invention which can compensate for manufacturing deviations of the thickness of the syringe’s flange, see paragraph 29 of Lanzi, therein improving the reliability of the invention.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly the independent claims:
WO 2013178512 A1
WO 2014154490 A2
WO 2011043714 A1
WO 2011123024 A1
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 BLAKE DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783