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 .
Claim Objections
Claim16 is objected to because of the following informalities:
Claim 16 lines 1-2, “a medicament” should read “the medicament” as it appears to be referring to the same medicament that was introduced in claim 15 line 2.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an engagement member” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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)(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) 1-7, 11-21 is/are rejected under 35 U.S.C. 102(a)(2) as being by Pedersen et al. (US 20190282767 hereinafter “Pedersen”).
Regarding Claim 1, Pedersen teaches (Figs 22-35) An injector device comprising:
a housing (101);
a cartridge (120) having a reservoir for medicament;
a needle unit (130) comprising a needle (125), wherein prior to use of the injector device the needle is sealed (122) from the reservoir;
a needle sleeve (170) rotatably mounted to the housing about an axis (interpreted that 170 is indirectly connected to housing 101 through cap 160; see [0172] teaching how 170 is forced to rotate with 160 due to the engagement between them); and
a guide (180, 183, 184) arranged to guide the needle unit into engagement with the cartridge as the needle unit or the cartridge moves axially (See Fig 22 and Fig 32, the needle unit 130 has moved axially),
wherein at least one of the needle unit or the cartridge is axially slidably mounted to the housing (see [0182] teaching how cartridge 120 moves axially distance 'z' within housing; also see Fig 22 to Fig 32, the needle unit 130 has moved axially within the housing), and
wherein the needle sleeve (170) comprises an engagement member (160) arranged to engage the needle unit (130) or the cartridge, the engagement member being adapted such that rotation of the needle sleeve moves the needle unit or the cartridge in an axial direction to move the needle into fluid communication with the reservoir (See [0172-0190] teaching how the interactions between cap 160, sleeve 170, needle unit 130 and cartridge 120 allow for rotational and axial movement which result in the needle moving from a disconnected state in Fig 22 to a connected state in Figs 32-35), and wherein the guide (180) prevents rotation of the needle unit relative to the cartridge (see [0186] teaching how 180 locks device in place after the needle is connected - this would be considered 'preventing rotation of the needle unit relative to the cartridge').
Regarding Claim 2, Pedersen teaches the injector device of claim 1, wherein the needle sleeve (170) is axially slidably mounted to the housing (101; indirectly slidably mounted to 101 through cap 160, and 180 which is within housing 101), and wherein after the rotation of the needle sleeve (see [0172] teaching first a rotation of 170 due to 160 needing to be rotated to be removed), the engagement member (160) disengages from the needle unit (130) or the cartridge so that the needle sleeve (170) can move axially independently of the needle unit (130) and the cartridge (120; see [0184-0191]).
Regarding Claim 3, Pedersen teaches the injector device of claim 1, further comprising a slot (184) arranged to prevent axial movement of the needle sleeve (170) until after the rotation of the needle sleeve (See [0190] teaching how sleeve 170 can move axially; this occurs only after the rotation and other interactions described between [0172-0190]).
Regarding Claim 4, Pedersen teaches the injector device of claim 3, wherein one of the housing (101) or the needle sleeve comprises the slot (184; see [0186] teaching that at this point guide 180 is locked to housing), and the other of the housing or the needle sleeve (170) comprises a protrusion (177) adapted to engage the slot (184), and wherein the slot comprises a circumferential portion for allowing the rotation of the needle sleeve (see Fig 25,182 is a 'circumferential portion'), and an axial portion (183) for allowing the axial movement of the needle sleeve (See [0184] and [0190]).
Regarding Claim 5, Pedersen teaches the injector device of claim 1, wherein the needle unit (130) comprises a needle body (outer surface of 130 including outer surface of 138), the needle body being arranged to engage the cartridge and/or the housing (101) during axial movement of the needle unit (130) or the cartridge (see [0186] teaching engagement between 138 and housing 101).
Regarding Claim 6, Pedersen teaches the injector device of claim 5, wherein the needle unit (130) is axially slidably mounted in the housing (101) and the cartridge (120) is fixedly mounted to the housing (101), and wherein the needle body (outer surface of 138) comprises a groove (ramp surface 135 and track surface 138) arranged to cooperate with a guide rail (105), the guide rail (105) extending from the cartridge or from the housing (101; see Fig 29a-29b and [0178]).
Regarding Claim 7, Pedersen teaches the injector device of claim 1, wherein the needle unit (130) further comprises catches (138) arranged to lock the needle unit (130) onto the cartridge or the housing (101) after axial movement of the needle unit or the cartridge moves the needle into the reservoir (see [0186] teaching engagement between 138 and housing 101).
Regarding Claim 11, Pedersen teaches the injector device of claim 1, further comprising a thread (135) disposed between the needle unit (130) and one of the cartridge or the housing (101), wherein the rotation of the needle sleeve (170) is adapted to cause rotation of the needle unit (130) or the cartridge such that the thread (135) moves the needle unit (130) or the cartridge in the axial direction as the needle sleeve is rotated (See [0166], [0168] and [0178]).
Regarding Claim 12, Pedersen teaches the injector device of claim 1, wherein the cartridge (120) comprises the medicament in the reservoir (see [0185]).
Regarding Claim 13, Pedersen teaches the injector device of claim 1, wherein the needle sleeve (170) is movable relative to the housing (101) from an extended position (Fig 22 and 32) in which the needle sleeve (170) covers an end (126) of the needle (125) to a retracted position (Fig 34) in which the end (126) of the needle (125) is exposed (See Fig 34).
Regarding Claim 14, Pedersen teaches the injector device of claim 1, wherein a distal end of the needle sleeve (170) defines an opening (See Fig 34, opening where 126 is extending from) configured to allow a distal end (126) of the needle (125) to pass through (See Fig 34).
Regarding Claim 15, Pedersen teaches (Figs 22-35) a method of using an injector device, the injector device comprising:
a cartridge (120) having a reservoir for medicament,
a needle unit (130) comprising a needle (125),
wherein prior to the use of the injector device, the needle (120) is sealed (122)from the reservoir (see Fig 22, this is prior to use position),
a needle sleeve (170) rotatably mounted to a housing (101) of the injector device about an axis (170 is indirectly mounted to 101 through cap 160), and
a guide (180) arranged to guide the needle unit (130) into engagement with the cartridge (120) as the needle unit (130) or the cartridge moves axially,
wherein the guide prevents rotation of the needle unit relative to the cartridge (see [0186] teaching how 180 locks device in place after the needle is connected - this would be considered 'preventing rotation of the needle unit relative to the cartridge');
wherein the method comprises:
rotating the needle sleeve (170) of the injector device about the axis relative to the housing (101) to move the needle unit (130) or the cartridge in an axial direction such that the needle is moved into fluid communication with the reservoir of the cartridge (See [0172-0190] teaching how the interactions between cap 160, sleeve 170, needle unit 130 and cartridge 120 allow for rotational and axial movement which result in the needle moving from a disconnected state in Fig 22 to a connected state in Figs 32-35).
Regarding Claim 16, Pedersen teaches the method of claim 15, further comprising:
initiating an injection of a medicament from the injector device (See [0191]), the initiating comprising: causing a distal end (126) of the needle (125) to pass through an opening (See Fig 34, opening where 126 is extending from) defined in a distal end of the needle sleeve (170; see Fig 34).
Regarding Claim 17, Pedersen teaches the method of claim 16, wherein initiating the injection of the medicament comprises moving the needle sleeve (170) of the injector device in a proximal direction (See [0191] and Figs 32-34).
Regarding Claim 18, Pedersen teaches the method of claim 15, wherein rotating the needle sleeve of the injector device comprises causing an engagement member (160) of the needle sleeve (170) to disengage from the needle unit (130) or the cartridge so that the needle sleeve (170) can move axially independently of the needle unit (130) and the cartridge (120; see [0184-0191]).
Regarding Claim 19, Pedersen teaches the method of claim 15, wherein rotating the needle sleeve (170) of the injector device comprises causing a protrusion (177) on one of the needle sleeve (170) or the housing to move to a portion of a slot (184) on the other of the needle sleeve or the housing (101; see [0186] teaching that 180 is locked to the housing) such that the needle sleeve (170) of the injector device can be moved in a proximal direction (See [0172-0190]).
Regarding Claim 20, Pedersen teaches the method of claim 15, wherein rotating the needle sleeve (170) of the injector device comprises causing the cartridge (120) of the injector device to move axially (see [0172] teaching first a rotation of 170 due to 160 needing to be rotated to be removed, also see [0182] teaching how cartridge 120 moves axially distance 'z' within housing).
Regarding Claim 21, Pedersen teaches the method of claim 15, further comprising: moving the needle sleeve (170) relative to the housing (101) from an extended position (Fig 22 and 32) in which the needle sleeve (170) covers an end (126) of the needle (125) to a retracted position (Fig 34) in which the end (126) of the needle (125) is exposed (See Fig 34).
Allowable Subject Matter
Claims 8-10 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.
As to claim 8, Pedersen teaches all elements of claim 1. Pedersen does not teach or make obvious the injector device wherein the needle unit is axially slidably mounted to the housing, and wherein the needle unit comprises a protrusion and the engagement member of the needle sleeve comprises a helical member arranged to engage the protrusion and move the needle unit axially in response to the rotation of the needle sleeve. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Pedersen to satisfy these limitations.
Claim 9 is dependent on claim 8.
As to claim 10, Pedersen teaches all elements of claim 1. Pedersen does not teach or make obvious the injector device wherein the cartridge is axially slidably mounted to the housing, and wherein the cartridge comprises a protrusion and the engagement member of the needle sleeve comprises a helical member arranged to engage the protrusion and move the cartridge axially in response to the rotation of the needle sleeve. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Pedersen to satisfy these limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Newman et al. (US 20110288491) teaches a needle unit with threading to help connect the needle unit to the injector.
Archilla et al. (US 20180117240) teaches an injector device with a needle shield that moves rotationally and axially to move the needle unit proximally in the device.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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