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 of Group 1 and Species A in the reply filed on 06/04/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 7-21 and 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups 2-3 and nonelected Species B-C, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/04/2026.
Claim Objections
Claim 5 is objected to because of the following informalities:
Regarding claim 5, the phrase “a driver including internal thread engaging the external thread of the lead screw“ in line 5 should read “a drive including internal threads engaging the external threads of the lead screw” for proper grammar,
Appropriate correction is required.
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) 1 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flaherty (U.S Patent Pub. No. 20030055380 A1).
Regarding claim 1, Flaherty discloses (Claim 1) a medication delivery system (200 in Fig. 3-4) comprising:
a container (30 in Fig. 3) for a medium (see para. 0052);
a plunger (204 in Fig. 3-4) disposed in the container (30, see Fig. 3-4, see para. 0057); and
a lead screw (202 in Fig. 3-4) axially fixed with respect to the container (30) and in threaded engagement with the plunger (204, see para. 0057 and 0059 – screw 202 is mounted within container 30 such that it can only rotate indicating it is axially fixed thereto, see para. 0060 – plunger 204 comprises insert 210 in threaded engagement with the screw 202),
where the lead screw (202) is disposed inside of the container (30, see Fig. 3-4), and the rotation of the lead screw (202) causes axial displacement of the plunger (204) with respect to the container (30, see para. 0058).
Regarding claim 22, Flaherty discloses (Claim 22) the medication delivery system (200) of claim 1, wherein the container (30) comprises an end cap (34 in Fig. 3) disposed at a distal end portion of the container (30, see para. 0056), the endcap comprising at least one of an outlet (36 in Fig. 3) for dispensing the medium (see para. 0056).
Claim Rejections - 35 USC § 103
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 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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty in view of Berney (W.O Patent Pub. No. 9415660 A1).
Regarding claim 2, Flaherty discloses the medication delivery system of claim 1, as discussed above.
Flaherty further discloses the limitations of (Claim 2) further comprising a motor (40 in Fig. 3) coupled to the lead screw (202) and disposed outside of the container (30, see Fig. 3 and para. 0061), the motor (40) selectively rotating the lead screw (202) in a first rotational direction (see para. 0061 – motor 40 is selectively activated by the processor to turn screw 202 in a first direction for drug delivery).
However, Flaherty fails to disclose the limitation wherein (Claim 2) the motor selectively rotates the lead screw in a second rotational direction opposite the first rotational direction.
Berney discloses a similar device for infusion (see Fig. 1) comprising a container (1 in Fig. 1) having an axially fixed lead screw (4 in Fig. 1) therein, a plunger (2 in Fig. 1) threadably engaged to the screw (4, see Fig. 1 and para. 017), and a motor (6 in Fig. 1) coupled through a gearbox (8 in Fig. 1) to the lead screw (4) such that it can bidirectionally control rotation of the lead screw (4, see para. 017-018). Thus, Berney teaches (Claim 2) wherein the motor (6) selectively rotates the lead screw (4) in one of a first rotational direction and a second rotational direction opposite the first rotational direction (see para. 017 – bidirectional control, see Fig. 8 and para. 088-090 – the bidirectional motor explicitly can rotate in a first direction and a second, reverse direction for dispensing and filling operations, respectively).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medication delivery system taught by Flaherty to operate its motor to turn the screw in a second rotational direction opposite the first rotational direction as taught by Berney. Berney provides that a bidirectional motor allows for a filling operation where liquid is sucked into the container by reversing the direction of rotation such that a container can be refilled and thus reused (see para. 088-096).
Regarding claim 3, modified Flaherty discloses the medication delivery system of claim 2, as discussed above. In modified Flaherty, Flaherty discloses the limitations of (Claim 3) wherein the rotating of the lead screw (202) in the first rotational direction advances the plunger (204) distally to inject the medium from the container (30, see para. 0057-0058).
In modified Flaherty, Berney discloses the limitations (Claim 3) the rotating of the lead screw (4) in the second rotational direction advances the plunger (2) proximally to draw in the medium into the container (1, see para. 017 and 088-090).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty in view of Berney as applied to claim 2 above, and further in view of Moberg et al. (U.S Patent Pub. No. 20080051727 A1, “Moberg”).
Regarding claim 4, modified Flaherty discloses the medication delivery system of claim 2, as discussed above.
While Flaherty discloses the medication delivery system (200 in Fig. 3) may comprise a rotational drive assembly (4) with reference to Fig. 3 as an electric motor (40) connected to an end of the lead screw (202, see para. 0061), and that other forms of rotational drive assemblies may be other motors, or solenoids, or linear actuators that drive ratcheting gear assemblies, Flaherty does not explicitly disclose (Claim 4) further comprising a gear mechanism transferring rotation of the motor to the lead screw.
Moberg discloses a medication delivery system (see Fig. 8-9) comprising a container (126 in Fig. 9) having a lead screw (127) axially fixed therein (see para. 0094), a plunger (134 in Fig. 9) threadably engaged with the lead screw (127, see para. 0094), and a motor (144 in Fig. 8) for driving rotation of the lead screw (127, see para. 0098), wherein Moberg teaches (Claim 4) further comprising a gear mechanism (154 in Fig. 9) transferring rotation of the motor (144) to the lead screw (127, see para. 0098-0099 – motor 144 is coupled to a drive linkage 154 which may be in the form of a gear mechanism to transfer rotation to lead screw 127).
Since Flaherty discloses a medication delivery system comprising an electric motor connected to a lead screw for driving rotation of a lead screw, and Moberg discloses a similar medication delivery system comprising a motor connected to a gear mechanism connected to a lead screw for driving and transferring rotation to the lead screw, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medication delivery system comprising the electric motor and lead screw of modified Flaherty to comprise a gear mechanism therebetween for transferring rotation of the motor to the lead screw as taught by Moberg. Moberg teaches that a drive linkage such as a gear mechanism operably connected between the motor and lead screw provides torque conversion, for example, to increase torque or decrease rotational speed at the lead screw, relative to the torque and speed output of the motor (see para. 0063).
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty in view of Lind et al. (W.O Patent Pub. No. 2007145644 A1, “Lind”).
Regarding claim 5, Flaherty discloses the medication delivery system of claim 1, as discussed above.
Flaherty further discloses the limitations of (Claim 5) wherein the plunger (204 in Fig. 3-4) comprises:
a stopper (204 in Fig. 3-4, see para. 0060);
a driver (210 in Fig. 3-4) including internal thread engaging the external thread of the lead screw (202) to advance the plunger (204) when the lead screw (202) is rotating (see para. 0060 – plunger 204 comprises a rigid insert 210 with internal threads for engaging the external threads of lead screw 202 for advancing the plunger 204),
wherein at least one of the driver and the stopper (204) comprises an exterior surface to seal to an inside diameter of the container (30, see para. 0057 and 0060 – stopper 204 is comprised of a flexible material for forming a seal at its exterior surface with the reservoir 30).
However, Flaherty fails to disclose (Claim 5) that the stopper includes internal threads engaging external threads of the lead screw to seal off the medium from leaking past the plunger.
Lind discloses a spraying device having a fluid dispensing cartridge (20 in Fig. 2), wherein said cartridge (20) defines the container and includes a lead screw (40 in Fig. 2) axially fixed therein (see p.15, lines 5-25), and a plunger assembly (50, 70 in Fig. 2 and 9) threadably engaged with the lead screw (40, see Fig. 2). Lind teaches (Claim 5) wherein the plunger (50, 70) comprises:
a stopper (70 in Fig. 9) including internal threads engaging external threads of the lead screw (40) to seal off the medium from leaking past the plunger (50, 70, see p.13 lines 19-27 – p.14, lines 1-20);
a driver (50 in Fig. 9) including internal thread engaging the external thread of the lead screw (40) to advance the plunger (50, 70) when the lead screw (40) is rotating (see Fig. 9 and p.12, lines 24-28 – p.13, lines 1-13),
wherein at least one of the driver (50) and the stopper comprises an exterior surface to seal to an inside diameter of the container (20, see Fig. 2 and p.12, lines 24-28 – p.13, lines 1-13).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plunger assembly taught by Flaherty to be substituted with the plunger assembly of Lind such that it would comprise the stopper (70) and driver (50) as illustrated in Fig. 9 of Lind. Lind provides that such a plunger configuration provides improved sealing pressure against leakage around both the lead screw and along the interior surface of the container (see p.13 lines 19-27 – p.14, lines 1-20). Examiner further notes Lind discloses several alternative embodiments of plunger assemblies indicating that said assemblies are substitutable with one another.
Regarding claim 6, modified Flaherty discloses the medication delivery system of claim 5, as discussed above. In modified Flaherty, Lind discloses (Claim 6) wherein the plunger (50, 70 in Fig. 9) is unitarily formed to comprise the stopper (70), the driver (50), and the exterior surface (exterior surface of 50, see Fig. 9 and p.13, lines 26-27– the seal 70 and piston 50 form a single unit that moves together and thus are unitarily formed).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights