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
Claim(s) 11-12 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03 February 2026. Applicant traverses the requirement inasmuch as Applicant believes that Examiner’s search burden would not be undue by common examination of Species D and E. However, this is not persuasive. Specifically, while Species D and E do include shared subject matter pertaining to a blocking element which is moved in then proximal direction, they contrast one another with respect to the structure of the locking sleeve 18 (see Par. 75) as well as how the latching elements (21f) are arranged (see Par. 74 and 76), these distinction creating independent species in light of the claims. To the extent that Applicant may be able to construct allowable, generic claims these species will be rejoined at that time, but until such point any subject matter specific to one species, but not the other species will remain subject to restriction thereby reducing Examiner’s burden and expediting the determination of allowable subject matter.
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.
Claim(s) 2, 17, and dependents is/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 2, Examiner submits that the instant claim is indefinite as the specification lacks clear antecedent basis for mapping the claim terminology to the more detailed disclosed invention such that meaning of the preposition arranged “on” the rotating drive element and adverb “directly” blocks the drive element is unclear. Specifically, the instant claim recites “the drive comprises a rotating drive element”. This “drive element” is never explicitly identified in the detailed description of the invention. The phrase is used in a typically conclusory manner except for a single recitation in Par. 0014 that “the drive comprises a rotating drive element in the form of a threaded rod for moving the propelling member…” which would seem to point to the “threaded rod 21a” as comprising this “rotating drive element”.
However, the “grid comprising a multiplicity of latching elements” is not disclosed as being part of this threaded rod, but rather the latching elements (22c) are provided on the propelling sleeve (22a). While the propelling sleeve (22a) is provided “on” the threaded rod (21a – see Fig. 2) it is unclear, based on the detailed disclosure, whether it would really be appropriate to characterize the latching elements (22c) of the sleeve (22a) to be “on” the drive element (21a) – see characterization of the invention Par. 27, 57, 64, 65 – re: “the grid is connected axially fixedly to the propelling member and in particular is arranged on the propelling member”, “the grid of the propelling sleeve”, “the propelling sleeve 22a also has a grid with latching elements 22c”. But should this indirect satisfaction of the preposition “on” in “on the rotating drive element” be permissive in the instant claim it does not appear that there would be any consideration to the engagement element “directly” blocking the drive element.
In the originally filed claims of the parent PCT filing, Applicant identifies the “antriebselement” (drive element) as the threaded rod “21a”, suggesting that the original intent of this limitation is indeed to identify the “drive element” as the “threaded rod” relying on this indirect satisfaction of the “on” preposition, which confounds the interpretation of “directly blocks” since the engagement elements (23e) do not directly engage with the threaded rod.
Elsewhere, Applicant uses the phrase “drive element” as an apparent analog to “an energy store element” (Par. 3), wherein in the instant invention the “energy store element” is provided in the “form of a pretensioned discharging spring” (Par. 12). While this phrasing is never explicitly used in reference to any specific embodiment identified in the detailed disclosure, Examiner does note that some embodiments include a “spring coil” (21b) which has a “distal extension” (21d) on which latching elements (21f) are provided (see Fig. 11b and 14b), wherein in this embodiment the latching elements (21f) stop rotational movement by engaging with a projection (23e)/“engagement elements” of a “blocking unit 23”. However, should this be the intended interpretation of Claim 2 it is confounded by failure for Applicant to expressly identify the “distal extension” of the “spring coil” as the “rotating drive element”.
Regarding Claim 17, like Claim 2, Applicant recites “the drive comprises a rotating drive element, wherein the multiplicitly of latching elements are arranged on the rotating drive element, and wherein the engagement element directly blocks the drive element in an axial coupling stroke”. However, as noted above, the language used here in the claims deviates substantially from that used in the detailed description and creates confusion as to the metes and bounds of “on” and “directly”.
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) 1, 13, 14, 15, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2016/0331905 (“Aneas”).
Regarding Claim 1, Aneas discloses an autoinjector (1), comprising:
a housing (2);
a propelling member (62);
a drive (16) configured to move the propelling member in a discharge movement in a longitudinal direction relative to the housing for automatically discharging a liquid product contained in a product container (80) held in the housing in an axially fixed manner (Par. 44, 54);
a needle-guard spring (14) for pretensioning a needle-guard sleeve (10) in a distal direction (Par. 37, 38), the needle-guard sleeve configured to move in a proximal direction in an actuating movement when the autoinjector is pressed against an injection site, and to move in the distal direction in a needle-guard movement when the autoinjector is removed from the injection site (Par. 46-47, 53, 57-58, 61);
a grid (64) comprising a multiplicity of latching elements (640); and
an engagement element (42) which, by an engagement in the grid (see e.g. Fig. 7), is able to block a discharging movement of the propelling member, wherein when the autoinjector is removed from the injection site without completely discharging the liquid product, the engagement element is pushed into the engagement with at least one of the multiplicity of latching elements by a pretensioned spring (41, Par. 43, 49, 54, 58 – re: “elastic return movement of the lever 41” whereby the lever’s resiliency serves as a pretensioned leaf-type spring).
Regarding Claim 13, Aneas discloses a locking element (44) with a locking surface configured to secure the engagement of the engagement element in a locking position held by the needle-guard spring (i.e. after the injection is complete the shoulder 440 of the locking element 44 is brought into engagement with the bolt 104 to securely lock the position of the engagement element in a “locking position” – see Fig. 11 – which is held by the restorative force of the needle guard spring to maintain element 10 in position – see Par. 64).
Regarding Claim 14, Aneas discloses the locking member is non-releasably held in the locking position (Par. 64).
Regarding Claim 15, Aneas discloses wherein locking element is coupled in the proximal direction in the locking position with the needle-guard sleeve locked in a needle-guard position (Par. 64 – i.e. proximal directional movement of the guard sleeve is prevented), and wherein the locking element serves as a switching sleeve which is coupled axially to the needle-guard sleeve (i.e. 440 is part of the sleeve of the housing and is coupled to the needle-guard sleeve at 104).
Regarding Claim 16, Aneas discloses an autoinjector (1), comprising:
a housing (2);
a propelling member (62);
a drive (16) configured to move the propelling member in a discharge movement in a longitudinal direction relative to the housing for automatically discharging a liquid product contained in a product container (80) held in the housing in an axially fixed manner (Par. 44, 54);
a needle-guard spring (14) for pretensioning a needle-guard sleeve (10) in a distal direction, the needle-guard sleeve configured to move in a proximal direction in an actuating movement when the autoinjector is pressed against an injection site, and to move in the distal direction in a needle-guard movement when the autoinjector is removed from the injection site (Par. 37-38, 46-47, 53, 57-58, 61); and
a coupling comprising an engagement element (42) and a multiplicity of latching elements (640), wherein the engagement element is able to block the discharge movement of the propelling member by an engagement in at least one of the multiplicity of latching elements (see Fig. 7), and wherein, when the autoinjector is removed from the injection site without completely discharging the product, the engagement element is pushed into the engagement with the at least one of the multiplicity of latching elements by a pretensioned spring (41 – Par. 58-59).
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.
Claim(s) 1-10, 13-20, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0169346 (“Hotstettler”) in view of U.S. Publication No. 2016/0331905 (“Aneas”).
Regarding Claims 1 and 16, Hotstettler discloses an autoinjector, comprising:
a housing (2);
a propelling member (7);
a drive (11) configured to move the propelling member in a discharge movement in a longitudinal direction relative to the housing for automatically discharging a liquid product contained in a product container (13) held in the housing in an axially fixed manner (see Fig. 4-5 in series; Par. 111);
a needle-guard spring (10) for pretensioning a needle-guard sleeve (3) in a distal direction, the needle-guard sleeve configured to move in a proximal direction in an actuating movement when the autoinjector is pressed against an injection site, and to move in the distal direction in a needle-guard movement when the autoinjector is removed from the injection site (Par. 56, 98, 114, 117, 122)
Hotstettler discloses the invention substantially as claimed except that that the device comprises a coupling comprising a “grid” of a “multiplicity of latching elements” configured to engage with an “engagement element” to block a discharging movement of the propelling member, wherein when the autoinjector is removed from the injection site without completely discharging the liquid product, the engagement element is pushed into the engagement with at least one of the multiplicity of latching elements by a pretensioned spring. Hotstettler discloses disclose an engagement element (6a) which engages with a corresponding latching element (7a) to block a dischargement movement of the propelling member (Par. 112) via a pretensioned spring (6C – re: the arms serve as leaf springs resiliently biased into the latching element), but this is provided only in a singular fashion with no specific consideration as to blocking injection incident to premature removal of the device from the injection site without complete discharge of the product.
However, Aneas discloses that one problem with autoinjectors is that premature release of injection pressure can interrupt delivery and cause loss of medication (Par. 15). In order to prevent this Aneas discloses a multiplicity of latching elements (640) disposed as a longitudinal grid (64) for engaging with a corresponding engagement element (42) such that it is able to block a discharging movement of the propelling member, wherein when the autoinjector is removed from the injection site without completely discharging the liquid product, the engagement element is pushed into the engagement with at least one of the multiplicity of latching elements by a pretensioned spring (Par. 57-59).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a plurality of latching elements distributed in a longitudinal grid to interface with the engagement element in the invention of Hotstettler, as disclosed by Aneas, in order to allow the engagement element to re-engage the propelling member in a blocking arrangement during premature release of the injection pressure to thereby ensure that medication is not accidentally wasted by being dispensed outside the patient tissue. It has been held that mere duplication of the parts of an invention is obvious, requiring only routine and customary skill in the art when no new or unexpected result is produced, see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Here, Aneas demonstrates that by duplicating the latching elements of an injector in a longitudinal grid the expected results of permitting blocking engagement to occur along the length of partial injection should the injection pressure be released is expected and is beneficial for preventing loss of medication associated with prematurely lifting/withdrawing the injector.
Regarding Claims 2 and 17, Hostettler, as modified, discloses the drive to comprise a rotating drive element (see e.g. first spring 9 and threaded rod 11), wherein the multiplicity of latching elements (see generally 7a, duplicated in view of Aneas) are arranged on the rotating drive element (see Fig. 2a – i.e. drive member 7 is sleeved over the threaded rod), and wherein the engagement element directly blocks the drive element in an axial coupling stroke (Par. 112).
Regarding Claims 3 and 18, Hostettler discloses the axial coupling stroke of the engagement element is released by the needle-guard movement of the needle-guard sleeve (Par. 62).
Regarding Claim 4, Hostettler during the axial coupling stroke, the engagement element is moved in the proximal direction by the needle-guard spring (Par. 31).
Regarding Claim 5, Hostettler, as modified, discloses the multiplicity of latching elements and the engagement element comprise corresponding coupling surfaces (i.e. the borders of the recess 7a engage with the edges of engagement element 6a – with duplication of the recesses being obvious in view of Aneas) the coupling surfaces formed obliquely relative to the longitudinal direction such that a force can be exerted on the engagement element in the proximal direction by a torque of the drive element (Par. 112, 118).
Regarding Claim 6, Hostettler discloses the engagement element is a part of a coupling, and as a result of the actuating movement of the needle-guard sleeve, directly releases the drive element for rotation (Par. 117).
Regarding Claims 7, Hostettler discloses the coupling comprises a first coupling element (6a), which can be removed, by an axial triggering stroke, from a second coupling element (7a) for triggering the rotation, and wherein the coupling comprises a third coupling element (6a), which can engage, by the axial coupling stroke and via a coupling surface, in a fourth coupling element (7a – duplicated in view of Aneas) for blocking the rotation of the drive element, the fourth coupling element including at least one of the multiplicity of latching elements.
Regarding Claim 8, Hostettler discloses the first and third coupling elements and the second and fourth coupling elements are identical (see the left and right arms 6c of the retaining element 6 defining the respective first and third coupling elements corresponding to the multiplicity of latching elements).
Regarding Claim 9, Hostettler discloses the first and third coupling elements are identical (see Fig. 1 – i.e. the elements 6a provided on respective left and right arms 6c), and the second and fourth coupling elements are axially spaced apart by a sum of the axial triggering stroke and the axial coupling stroke (see modification in view of Aneas to provide a longitudinally extending multiplicity of latching elements).
Regarding Claim 10, Hostettler discloses a first coupling element (6a) is removable by a distal triggering stroke from a second coupling element (7a) for triggering a rotation of the drive element, and a third coupling element (6a) can engage in a fourth coupling element (7a) for blocking the rotation of the drive element by a proximal coupling stroke.
Regarding Claim 13, Hostettler discloses a locking element (8) with a locking surface (8a) configured to secure the engagement of the engagement element in a locking position held by the needle-guard spring (Par. 118, 122).
Regarding Claim 14, Hostettler discloses the locking member is non-releasably held in the locking position after the injection has finished (Par. 122).
Regarding Claim 15, Hostettler discloses the locking element is coupled in the proximal direction in the locking position with the needle-guard sleeve locked in a needle-guard position (Par. 122), and wherein the control element and/or the locking element serves as a switching sleeve which is coupled axially to the needle-guard sleeve (Par. 122).
Regarding Claim 19, Hostettler discloses the coupling comprises a first coupling element (6a) and a second coupling element (7a), wherein the first coupling element can be removed from the second coupling element to release the drive element for rotation by an axial triggering stroke caused by the actuating movement of the needle-guard sleeve (Par. 112).
Regarding Claim 20, Hostettler discloses during the axial coupling stroke, the engagement element is moved in the proximal direction by the needle-guard spring (Par. 62).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 03/12/2026