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 .
Election/Restrictions
Applicant's election with traverse of Species A in the reply filed on 3/13/2026 is acknowledged. The traversal is on the ground(s) that the claims read on the rotational mechanism that is found in both species. This is found persuasive and the previous requirement for election of species is withdrawn.
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 23-26, 31-33 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 23 recites “the first rotational position” and “the second rotational position” in lines 2-4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the limitations are interpreted to be the same as “the first position” and “the second position” as introduced in claim 16.
Claims 24-26 are rejected due to their dependency on claim 23.
Claim 31 recites “an additional guide track” and “an additional projection” in lines 2-4. The current language of the claim appears to state that there are three guide tracks and three projections (claim 16 already introduces a first guide and a second guide and respective projections), however the instant specification and Figures only appear to disclose two guide tracks, an inner guide and an outer guide. It is unclear if the ‘additional guide track’ and ‘additional projection’ are a third set of guides and projections or if they are the same scope as the first guide and projection disclosed in claim 16. For purposes of examination, the examiner is interpreting that the limitation refers to the same guide and projection on the needle sleeve as introduced in claim 16.
Claim 31 recites “a first position” and “a second position” in the last two lines of the claim. It is unclear if these are and additional set of “first position” and “second position” or if they are referring to the same first position and second position as introduced in claim 16. For purposes of examination the limitations are interpreted to be the same as “the first position” and “the second position” as introduced in claim 16.
Claim 32 is dependent on claim 31.
Claim 33 recites “the distal end” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 16-18 and 20-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giambattista et al. (US 20150335829 hereinafter “Giambattista”).
Regarding Claim 16, Giambattista teaches (Figs 1-2, 7-8 and 11-12) an injector device comprising:
a housing (10) having a proximal end (end closest to 114 in Fig 1) and a distal end (end closest to 12 in Fig 1), and configured to receive a container (84) of medicament (See [0046]);
a needle sleeve (12) mounted within the housing (10) and movable between an extended position (Fig 11) in which the needle sleeve (12) at least partially extends from the distal end of the housing (10), and a retracted position (Fig 12) in which the needle sleeve (12) is received further within the housing (10) than in the extended position (Fig 11);
a piston rod (102) movable within the housing (10);
an energy source (108) configured to bias the piston rod (102) towards the distal end of the housing to engage the container of medicament when received within the housing (See [0064]); and
a release mechanism (82) configured to control actuation of the piston rod, the release mechanism comprising a rotatable member (82) disposed within the housing (10) and in cooperating engagement with the needle sleeve (12) such that movement of the needle sleeve (12) from the extended position to the retracted position causes the rotatable member to rotate within the housing from a first position to a second position (see [0059]), at least one of the rotatable member (82) and the needle sleeve comprising a first guide track (90), wherein at least a portion of the first guide track has a helical or spiral shape (See [0062] teaching circumferential sections, this is considered to be a 'helical or spiral shape'), the other of the rotatable member and the needle sleeve (12) comprising a track follower (30) in engagement with the first guide track to rotate the rotatable member (see [0076]);
wherein the rotatable member (82) is in cooperating engagement with the piston rod (102) by a second guide track (100) formed on one of the rotatable member (82) and the piston rod, and a projection (104) formed on the other of the rotatable member and the piston rod (102), the projection being received within the second guide track (100), and the second guide track (100) being configured such that in the first position of the rotatable member, the piston rod (102) is prevented from movement under a force of the energy source (108), and in the second position of the rotatable member, the piston rod is free to travel in a distal direction of the injector device (See [0064], [0069] and [0076]).
Regarding Claim 17, Giambattista teaches the injector device according to claim 16, wherein in the second position of the rotatable member (82), the piston rod (102) is free to travel in the distal direction of the injector device under the force of the energy source (108; See [0064]).
Regarding Claim 18, Giambattista teaches the injector device according to claim 17, wherein in the second position of the rotatable member (82), the piston rod (102) is free to travel in the distal direction of the injector device to engage the container of medicament (84; see [0064]).
Regarding Claim 20, Giambattista teaches the injector device according to claim 16, wherein the second guide track (100) is open at a distal end of the rotatable member (See Fig 8, open end between ledges where 100I points to).
Regarding Claim 21, Giambattista teaches the injector device according to claim 16, wherein the rotatable member has a first section of a first diameter (See annotated Fig 8) and a second section of a second diameter (See annotated Fig 8), the movement of the piston rod (102) being from the second section towards the first section (See annotated Fig 8; longitudinal movement of plunger rod 102 follows the track 100 from Pos. I to Pos V, which is from a second section towards a first section).
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Annotated Fig 8 (Giambattista)
Regarding Claim 22, Giambattista teaches the injector device according to claim 16, wherein when the needle sleeve (12) is in the extended position (Fig 11) the rotatable member (82) is in the first position (See [0076]), when the needle sleeve (12) has moved to the retracted position (Fig 12) the rotatable member (82) is in the second position (see [0059]), and wherein the rotation of the rotatable member is exclusively actuated by movement of the needle sleeve (See [0076], this specific portion of rotation of 82 is done only by the movement of 12).
Regarding Claim 23, Giambattista teaches the injector device according to claim 16, wherein the second guide track (100) comprises a first portion (100V) in which the projection (104) is received when the rotatable member (82) is in the first rotational position (see [0069]), and a second portion (100VI) in which the projection (104) is received when the rotatable member (82) is in the second rotational position (see [0076]) and when the piston rod (102) moves within the housing (10).
Regarding Claim 24, Giambattista teaches the injector device according to claim 23, wherein the first portion (100V) of the second guide track extends in a substantially circumferential direction of the rotatable member (82), and the second portion (100VI) of the second guide track extends in a substantially longitudinal direction of the rotatable member (See Fig 8 and [0063] teaching circumferential and longitudinal sections).
Regarding Claim 25, Giambattista teaches the injector device according to claim 24, wherein the first portion (100V) of the second guide track (100) extends in a helical path (See [0063] defining 100V as "transversal and circumferential section" as such it is interpreted that it is a portion of a 'helical path') towards the second portion (100VI) of the second guide track (100).
Regarding Claim 26, Giambattista the injector device according to claim 23, wherein the first portion (100V) of the second guide track extends in a substantially perpendicular direction to the second portion (100VI) of the second guide track (See Fig 8, 100V and 100VI are perpendicular).
Regarding Claim 27, Giambattista the injector device according to claim 16, wherein the rotatable member (82) comprises a hollow cylindrical component (See Fig 9, 82 is hollow and cylindrical) and the piston rod (102) is disposed within the rotatable member (82; see Fig 2), the second guide track (100) is formed on an inner surface of the rotatable member (82; Fig 8), and the projection (104) is formed on an outer surface of the piston rod (102; Fig 9).
Regarding Claim 28, Giambattista teaches the injector device according to claim 16, wherein the second guide track (100) is defined between spaced walls (see [0063] teaching 100 is between two sets of ledge sections) projecting from a surface (inner surface) of the rotatable member (82).
Regarding Claim 29, Giambattista teaches the injector device according to claim 16, wherein the second guide track (100) comprises a recessed channel (100I - 100VII is a recessed portion between the two ledges described in [0063]) formed in a surface (inner surface) of the rotatable member (82), or the second guide track comprises a channel extending through a side wall of the rotatable member.
Regarding Claim 30, Giambattista teaches the injector device according to claim 16, wherein the release mechanism comprises a plurality of guide tracks (all sections 100I - 100VII) formed on one of the rotatable member (82) and the piston rod, and a plurality of projections (104) formed on the other of the rotatable member and the piston rod (102) and respectively received within the plurality of guide tracks (See [0064]).
Regarding Claim 31, Giambattista teaches the injector device according to claim 16, wherein the cooperating engagement between the needle sleeve (12) and the rotatable member (82) comprises (i) an additional guide track (90; see 112 rejection above, it is interpreted that ‘an additional guide track is the same as the first guide track of claim 16) formed on one of the rotatable member and the needle sleeve and (ii) an additional projection (20) formed on the other of the rotatable member and the needle sleeve (12), the additional projection (20) being received within the additional guide track (90), and the additional guide track (90) being configured in a helical path (See [0062] teaching circumferential sections, this is considered to be a 'helical or spiral shape') such that movement of the needle sleeve (12) from the extended position (Fig 11) to the retracted position (Fig 12) causes the rotatable member (82) to rotate within the housing from a first position to a second position (See [0059] and [0076]).
Regarding Claim 32, Giambattista teaches the injector device according to claim 31, comprising a plurality of additional guide tracks (portions 90I-90VII) formed on one of the rotatable member (82) and the needle sleeve, and a plurality of additional projections (20) formed on the other of the rotatable member and the needle sleeve (12) and respectively received within the additional guide tracks (See [0059] and [0076]).
Regarding Claim 33, Giambattista teaches the injector device according to claim 16, further comprising the container (84) of medicament received within the housing (10) between the piston rod (102) and the distal end (end closest to 12) of the injector device.
Regarding Claim 34, Giambattista teaches a method comprising:
moving a needle sleeve (12) within a housing (10) of an injector device from an extended position (Fig 11) in which the needle sleeve (12) at least partially extends from a distal end (end closest to 12 in Fig 1) of the housing to a retracted position (Fig 12) in which the needle sleeve (12) is received further within the housing (10) than in the extended position (Fig 11; also see [0049] teaching the movement of 12 between an extended position and a retracted position);
receiving a track follower (20) within a first guide track (90), wherein at least a portion of the first guide track has a helical or spiral shape (see [0062] teaches parts of 90 are circumferential this is considered ‘helical or spiral’), wherein the first guide track (90) is formed on one of a rotatable member (82) and the needle sleeve, and the track follower (20) is formed on the other of the rotatable member and the needle sleeve (12), the rotatable member (82) being part of a release mechanism of the injector device (See [0059]);
rotating the rotatable member (82) within the housing (10) from a first position to a second position as the needle sleeve is moved from the extended position to the retracted position (See [0059]);
receiving a projection (104) within a second guide track (100; see [0064] teaching how 104 interacts with 100) formed on one of the rotatable member (82; see [0064] teaching 100 is on inner surface of 82) and a piston rod, the projection (104) being formed on the other of the rotatable member and the piston rod (102); and
moving the piston rod (102) in a distal direction of the injector device within the housing, by an energy source (108), to engage a container of medicament (84) received within the housing (10) upon rotating the rotatable member (84) to the second position, wherein the movement of the piston rod (102) is prevented when the rotatable member (82) is in the first position and the movement of the piston rod is permitted when the rotatable member is in the second position (See [0059], [0064] and [0076]).
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.
Claim(s) 19 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giambattista et al. (US 20150335829) in view of Edhouse et al. (US 2013046238 hereinafter “Edhouse”).
Regarding Claim 19, Giambattista teaches all elements of claim 16 as described above. Giambattista does not specify the injector device wherein the first guide track extends around at least 90 degrees of a circumference of the rotatable member.
Edhouse teaches ([0024], [0026] and [0029]) a guide track that extends at least 90 degrees of a circumference of the rotatable member.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first guide track of Giambattista such that the guide track extends at least 90 degrees of a circumference of the rotatable member as taught by Edhouse. One of ordinary skill in the art would recognize this is an alternative design that provides the same expected result of rotating the portion of the device in order to deliver medication (See Edhouse [0039-0040]).
Regarding Claim 35, Giambattista teaches all elements of claim 34 as described above. Giambattista does not specify the method wherein the first guide track extends around at least 90 degrees of a circumference of the rotatable member.
Edhouse teaches ([0024], [0026] and [0029]) a guide track that extends at least 90 degrees of a circumference of the rotatable member.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first guide track of Giambattista such that the guide track extends at least 90 degrees of a circumference of the rotatable member as taught by Edhouse. One of ordinary skill in the art would recognize this is an alternative design that provides the same expected result of rotating the portion of the device in order to deliver medication (See Edhouse [0039-0040]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Daniel (US 20130041347) teaches an injector device with a rotatable member with multiple guide tracks that interact with both a needle sleeve and a plunger rod.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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 at (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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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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