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 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) 1-2, 5-6, and 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2003/0199824 to Mahoney et al. (Mahoney hereinafter) in view of US Pre-Grant Publication 2003/0115981 to Stoianovici et al. (Stoianovici)
Regarding claim 1, Mahoney teaches a device (10) for delivering fluid do a user, comprising a reservoir (30), a plunger (204), a threaded lead screw (202), an actuator (214, 220), and a processor (50, see e.g. paragraph 59). Mahoney does not teach that the lead screw is a multi-start lead screw. Stoianovici teaches a ball-worm transmission generally, and particularly teaches a driven gear (200) and a multi-start lead screw (100). Stoianovici teaches that the lead screw may be made multi-start for when high power/low transmission ratios are desired (paragraph 60). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a multi-start lead screw as taught by Stoianovici in the device of Mahoney in order to improve its high power and/or low transmission ratio aspects.
Regarding claim 2, Mahoney teaches a worm drive (i.e. the threads of the lead screw) and a ratchet gear (214, see e.g. Fig. 4 and paragraph 75).
Regarding claim 5, Mahoney teaches a restrictor (216) which prevents linear movement of the lead screw (e.g. along the axis of the shape memory actuator 220) but permits rotational movement.
Regarding claim 6, inasmuch as the restrictor contacts and supports the actuator (at 214) and the lead screw (202, at least indirectly), it serves as a bearing surface.
Regarding claim 9, Mahoney teaches a tube nut (208).
Regarding claim 10, in view of Stoianovici, which teaches multiple thread starts, it would have been obvious to use two, three or four starts in the device of Mahoney as these overlap the range disclosed by Stoianovici.
Regarding claim 11, Mahoney teaches a first drive mechanism (220a) and a second drive mechanism (220b). The first (220a) does not rotate the wheel (i.e. an increment of zero) and the second rotates the wheel (one tooth of rotation).
Regarding claim 12, Mahoney teaches that the first mechanism indirectly rotates the lead screw (i.e. by providing a reset of the finger 222) and the second mechanism directly rotates the lead screw (by pulling a tooth with the finger 222).
Regarding claim 13, Mahoney teaches that the lead screw is disposed on a right side of the plunger (see Fig. 3).
Regarding claim 14, Mahoney teaches that the lead screw is coaxial with the piston (see Fig. 3).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney in view of Stoianovici as applied to claim 1, and further in view of US Pre-Grant Publication 2018/0015228 to Stefanov et al. (Stefanov).
Regarding claim 3, Mahoney teaches the limitations of claim 1 as discussed above, and further teaches a shape memory wire (220) and a spring engaging the pawl (122, “compression or other type”). Mahoney does not teach an ortho-planar spring. Stefanov teaches another medicament delivery device generally, and particularly teaches a locking device (80, 90, 110) including an ortho-planar spring (110). Stefanov teaches that this spring provides an axial bias and thereby allows for locking and unlocking of a linear travel device (paragraphs 70, 83). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use an ortho-planar spring as taught by Stefanov to the device of Mahoney to provide the desired bias.
Regarding claim 4, Mahoney teaches a finger (222), a ratchet wheel (214), and a locking mechanism (244) at least indirectly fixed to the ortho-planar spring and having a tooth configured to mate with the ratchet wheel. The provision of multiple teeth would be obvious as the mere duplication of the illustrated tooth (244, see MPEP 2144.04 VI. B).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney in view of Stoianovici as applied to claim 1 above, and further in view of US Pre-Grant Publication 2021/0341036 to Mock et al. (Mock).
Regarding claims 7 and 8, Mahoney teaches claim 1 as discussed above. Mahoney does not teach a clutch with a clamping torsion spring. Mock teaches a rotational clutch (320) configured to clamp around a drive shaft in response to a controller signal (paragraph 89) via a torsion spring (1165, paragraph 85). Mahoney teaches that this allows selective actuation of the shaft (paragraph 89). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a clutch as taught by Mock to the device of Mahoney in order to allow for selective actuation of the leadscrew thereof.
Response to Arguments
Applicant's arguments filed 27 April 2026 have been fully considered but they are not persuasive.
With respect to the argument that the motivation to combine would run counter to Mahoney’s design goals, the examiner is not persuaded. First, Mahoney is silent to multi-start screws and therefore cannot be considered to teach away from their use. Second, applicant’s arguments are predicated on a section of the Mahoney reference which relates to an entirely different embodiment than that which is relied on herein. As such, the examiner holds that the applicant’s alleged “design goals” are not relevant to the rejection as set forth and therefore do not weigh against a conclusion of obviousness. Finally, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the examiner has clearly set forth the evidentiary basis for the conclusion as discussed above and the combination is wholly based on information available at the time of the effective filing date of the application.
With respect to claim 9, the applicant notes that the art has no single definition of a “tube nut”. Furthermore, as part of the plunger, the end portion (208) is “driven along the lead screw when actuated by the actuator”. The claim does not require any particular structure of the tube nut, nor does it require any functional cooperation between the tube nut and the actuator.
With respect to claim 5, as applicant acknowledges, Mahoney’s bracket provides mounting and axial restraint “with no relationship to a reservoir fill state”. The examiner notes that the claim is silent to the periods of time other than a fill cycle, and as such does not disclaim a restrictor which provides restraint during those other times.
In view of the above, the examiner maintains the obviousness rejections as set forth above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 11 June 2026
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