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 Group 3 in the reply filed on 05/25/2026 is acknowledged. The traversal is on the ground(s) that the dispensing unit is not the special technical feature, rather the resetting element is. This is not found persuasive because the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). In this instance, Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a dispensing unit having a compartment filled with a fluid to be ejected, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Keitel et al. (U.S. Patent Publication No. 2020/376205 A1. Keitel et al. discloses a dispensing unit (distal end of 20) having a compartment (8) filled with a fluid to be ejected (Fig. 1).
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim(s) 18 is/are objected to because of the following informalities:
Claim 18, line 4, “a stops”. It should be amended as “a stop”.
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.
Claim(s) 7 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
Claim 7 recites the limitation "the coupling part" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 2-11, 13-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gabriel et al. (US 2010/0168677).
Regarding claim 19, Gabriel discloses
A kit (figs. 1-36 and pars. 0045-0097) comprising:
a delivery device (30, fig. 1); and
a dispensing unit (42, fig. 1),
the delivery device (1) comprising a housing (52 and 66, figs. 1 and 5-7), a resetting element (88, fig. 2 and par. 0054) and a piston rod (94, fig. 2 and par. 0054),
the dispensing unit (42) comprising a compartment or a cavity (compartment/cavity of 42 as shown in fig. 2) to receive a fluid (32 within carpule 34, fig. 2 and par. 0045) to be ejected by the delivery device (30),
the dispensing unit (42) configured to be mounted to the housing (52/66, par. 0051),
the piston rod (94) configured to move in a proximal direction (downward direction/toward the injection site, par. 0064) to eject the fluid (par. 0064),
the resetting element (88) configured to rotate relative to the housing when no dispensing unit is attached to the housing and to thereby move the piston rod in a distal direction back into the housing (par. 0058), and
the dispensing unit (42) configured to press axially against the resetting element (88) upon being mounted to the housing to move the resetting element in the distal direction into the housing (par. 0057), and thereby rotationally lock the resetting element with respect to the housing (par. 0057).
Regarding claim 2, Gabriel discloses
The kit according to claim 19, wherein the resetting element (88) is configured to be directly contacted and pressed axially by a part (distal part with element 104) of the dispensing unit (42) upon mounting the dispensing unit (42) to the housing (52/66, fig. 11 and pars. 0053-0058), the part (distal part of 42) comprises a connector (48) of the dispensing unit (42) to engage with a connector (50) of the housing (52), the part and the connector of the dispensing unit are formed as a one piece or monolithic element (see fig. 2).
Regarding claim 3, Gabriel discloses
The kit according to claim 19, wherein the resetting element (88) is configured to be directly contacted and pressed axially by a cartridge holder (34) of the dispensing unit (42) upon mounting the dispensing unit (42) to the housing 952, see fig. 11), and the cartridge holder (34) is configured to receive a cartridge having the compartment filled with the fluid to be ejected (see fig. 2. Examiner notes “configured to receive …” is interpreted as functional limitation, and the limitation “a cartridge” is not positively recited in claim 3).
Regarding claim 4, Gabriel discloses
The kit according to claim 19, wherein the piston rod (94) is rotationally fixed to the resetting element (88) and free to move in an axial direction of the delivery device (30) with respect to the resetting element (see par. 0054 for 88 and 94 rotation blocked during an injection and 94 presses with its proximal end against 36 and displaces it in the direction toward needle so that fluid is expelled there), or the resetting element is configured to be moved along the axial direction of the delivery device when the dispensing unit is being attached to the housing of the delivery device until the resetting element contacts a coupling site of the housing where the resetting element is rotationally fixed with respect to the housing (Examiner notes: claim 4 uses the “or” statement between two limitations, therefore, either the first limitation or the second limitation is not required in claim 4. Gabriel reads on the first limitation of claim 4).
Regarding claim 5, Gabriel discloses
The kit according to claim 4, wherein the resetting element (88) comprises a first set of engagement features (86) with which the resetting element (88) is rotationally fixed to the housing (66) when the dispensing unit (42) is attached to the housing (52, par. 0054), and the housing (66) comprises a second set of engagement features (84) at the coupling site (see fig. 11), corresponding to the first set of engagement features of the resetting element such that the first and second set of engagement features engage with each other to rotationally fix the resetting element with respect to the housing when the dispensing unit is attached to the housing (par. 0054).
Regarding claim 6, Gabriel discloses
The kit according to claim 19, further comprising a coupling part (86/84) configured to rotationally fix the resetting element (88) with respect to the housing (66, fig. 11 and par. 0054).
Regarding claim 7, Gabriel discloses
The kit according to claim 4, wherein the coupling site is provided at the coupling part and the coupling site faces the resetting element (Examiner notes: see the rejection of claim 4 above for the second limitation of the “or” statement is interpreted as not positively recited in claim 4. Therefore, the limitation of “the coupling site” in claim 7 is also not positively required).
Regarding claim 8, Gabriel discloses
The kit according to claim 19, further comprising a biasing element (104) configured to bias the resetting element in the proximal direction (since 104 is compressed when 42 is coupled to 52, par. 0057).
Regarding claim 9, Gabriel discloses
The kit according to claim 19, further comprising a nut (88) threadedly engaged with the piston rod (94) and rotationally fixed during resetting of the piston rod such that rotation of the resetting element causes axial movement of the piston rod with respect to the housing (par. 0058) such that when rotating the resetting element around an axis of rotation, the piston rod is moved distally away from the cartridge, along the axis (par. 0058).
Regarding claim 10, Gabriel discloses
The kit according to claim 19, wherein the piston rod (94) comprises a stop feature (proximal surface of 94 that rest against 88, par. 0058) configured to limit axial movement of the piston rod in the distal direction by contacting an inner surface of the resetting element (inner surface of 88, par. 0058) such that the resetting element cannot be rotated, and the inner surface is disposed at a reception area of the resetting element (see fig. 11 and par. 0058).
Regarding claim 11, Gabriel discloses
The kit according to claim 19, wherein a connector (50) of the housing (52) is configured to be mounted to a corresponding connector (48) of the dispensing unit (42), the connector (50) is configured as a thread connection (see fig. 11 and par. 0057), or the connector is configured separate from the resetting element (Examiner notes: claim 11 uses the “or” statement between two limitations, therefore, either the first limitation or the second limitation is not required in claim 11. Gabriel reads on the first limitation of claim 11).
Regarding claim 13, Gabriel discloses
The kit according to claim 19, wherein the dispensing unit (42) comprises a cartridge holder (42) configured to be mounted to a connector (50) of the housing (52) of the delivery device (30) and configured to receive a cartridge filled with the fluid to be ejected (see fig. 2. Examiner notes “configured to receive …” is interpreted as functional limitation, and the limitation “a cartridge” is not positively recited in claim 13).
Regarding claim 14, Gabriel discloses
The kit according to claim 13, wherein the cartridge holder (42) is configured to non-releasably fix the cartridge to the cartridge holder after insertion of the cartridge into the cartridge holder (see fig. 2. Examiner notes “configured to non-releasably fix …” is interpreted as functional limitation, and the limitation “the cartridge” is not positively recited in claim 14).
Regarding claim 15, Gabriel discloses
The kit according to claim 14, wherein the cartridge holder (42) further comprises a fixing device (48) to fix the cartridge to the cartridge holder (see fig. 2. Examiner notes: “to fix…” is interpreted as functional limitation, and the limitation “the cartridge” is not positively recited in claim 15).
Regarding claim 16, Gabriel discloses
The kit according to claim 15, wherein the fixing device (48) is configured to engage with an annular rim of the cartridge (see fig. 2. Examiner notes: the limitation “configured to engage…” is interpreted as functional limitation, and the limitations “an annular rim” and “the cartridge” are not positively recited in claim 16).
Regarding claim 17, Gabriel discloses
The kit according to claim 13, wherein the cartridge holder (42) comprises a needle connector (47, figs.2-4 and par. 0051) to attach a needle to the cartridge holder and thereby pierce a seal at the proximal end of the cartridge by the needle (see fig. 2. Examiner notes: the limitation “to attach ….” is interpreted as functional limitation, and the limitations “a needle”, “a seal”, and “the cartridge” are not positively recited in claim 17), and the cartridge holder (42) comprises a stop feature (48) configured to prevent distal movement of the cartridge during attachment of the needle and piercing of the seal (see fig. 2. Examiner notes: the limitation “configured to prevent…” is interpreted as functional limitation, and the limitations “a needle”, “a seal”, and “the cartridge” are not positively recited in claim 17).
Regarding claim 18, Gabriel discloses
The kit according to claim 13, wherein the cartridge holder (42) comprises a biasing element (104, figs. 2 and 11, par. 0057) configured to bias the cartridge in the proximal direction into the cartridge holder after insertion (see fig. 2. Examiner notes: the limitation “configured to bias….” is interpreted as functional limitation, and the limitation “the cartridge” is not positively recited in claim 18), and the biasing element (104) is configured to bias the cartridge against a stops (proximal surface at the proximal portion of 42) located at a proximal end of the cartridge holder (see fig. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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