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 .
Response to Amendment
This office action is responsive to the amendment filed 18 March 2026. As direct by the amendment: claims 1-8 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 18 March 2026 have been fully considered but they are not persuasive.
Applicant argues on page 4 that Grimard does not teach a channel enabling fluid flow. As can be seen in figure 7, the sloped portion 214 allows for fluid to flow down the inclined surface through the area 112 and pass through to part 238. Therefore, it is reasonable to say that the portion 214 that is part of the channel structure enables the fluid flow by nature of its design and its function in conjunction with the parts 112 and 238 as the device operates together. Column 9, lines 51-67 explain how the by-pass channel works and how the sloping portion of the stopper enables the fluid flow.
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, 3-5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grimard et al. (US 5,899,881).
Regarding claim 1, Grimard discloses an elastomeric stopper (Fig. 2, 200) for a drug reservoir, comprising:
- a stopper body (201, 225) extending along a reference axis (208) between a leading end surface (234) and a trailing end surface (204) and having a generally cylindrical sidewall with an outer body diameter (Fig. 2, where the stopper has a sidewall and is cylindrical in shape),
- a circumferential convex sealing rib extending radially outwardly from the sidewall (226, where the ribs extend on the sidewall),
- a non-convex trim edge portion (214) at the trailing end surface (210b), the non-convex trim edge portion having an outer trim edge diameter which is greater than the outer body diameter (Fig. 2, where the portion 214 is non-convex and is greater diameter than at least part of the body portion of the stopper such as 206) and being axially spaced apart from the circumferential convex sealing rib, providing an annular recess therebetween (Fig. 2, where 210b is spaced from the convex portion and creates a recess),
further comprising a channel structure enabling fluid flow from the trailing end surface to the annular recess through the non-convex trim edge portion (214, 215, Col. 7, line 66-Col. 8, lines 1-19).
Regarding claim 3, Grimard discloses wherein the channel structure comprises at least one peripheral cut-out forming a part-cylindrical indentation in the non-convex trim edge portion (220, where the hollow chamber is cut out from the recess).
Regarding claim 4, Grimard discloses drug reservoir in combination with the elastomeric stopper of claim 1, the drug reservoir (Figs. 1 & 2) comprising:
- a reservoir body (100) comprising a generally cylindrical wall with an axially extending bypass channel therein (106),
- a proximal end section (102),
- a distal outlet end section (104),
- an elastomeric stopper (200) wherein the elastomeric stopper is slidably arranged between the distal outlet end section and the proximal end section (Fig. 1, where the stopper 200 is in the barrel between 102 and 104) and initially providing a fluid tight seal with the generally circular cylindrical wall proximally of the bypass channel, a front chamber thereby being defined by the distal outlet end section, a first portion of the reservoir body, and the elastomeric stopper (Col. 6, lines 47-65), and
- a rear stopper slidably arranged between the elastomeric stopper and the proximal end section, a rear chamber thereby being defined by the elastomeric stopper, a second portion of the reservoir body, and the rear stopper (Col. 9, lines 16-39).
Regarding claim 5, Grimard discloses further comprising an injection needle (400) with a lumen, the lumen being in fluid communication with the distal outlet end section (Col. 8, lines 37-51).
Regarding claim 7, Grimard discloses wherein the drug expelling mechanism comprises a plunger rod (116) operable to displace the rear stopper relative to the generally cylindrical wall (Col. 9, lines 40-46).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Grimard et al. (US 5,899,881) in view of Alheidt (US 2017/0056595).
Regarding claim 2, Grimard does not specifically disclose wherein the channel structure comprises at least one bore through the non-convex trim edge portion, the at least one bore having an inlet opening in the trailing end surface and an outlet opening in the annular recess.
Alheidt discloses a flushing syringe with a plunger and a stopper mechanism. Alheidt teaches wherein the channel structure comprises at least one bore through the non-convex trim edge portion, the at least one bore having an inlet opening in the trailing end surface and an outlet opening in the annular recess (Fig. 11, 263, where the springs are connected to one part of the end surface and are open near an annular recess) . It would have been obvious to one of ordinary skill in the art to modify the device of Grimard and make an opening in the stopper device that would allow for fluid flow in the device. It is well known in the art to have stoppers with multiple fluid flow components in order to improve plunger functionality (¶[0049] from Alheidt).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Grimard et al. (US 5,899,881) in view of Reihl (US 2002/0189705).
Regarding claim 6, Grimard does not specifically disclose wherein the distal outlet end section is closed by a penetrable self-sealing septum.
Reihl discloses a fluid transfer device that uses a plunger and a needle. Reihl discloses wherein the distal outlet end section is closed by a penetrable self-sealing septum (Fig. 1, 32, ¶[0047]). By modifying the device of Grimard to include a self-sealing septum (Fig. 1, 32 from Reihl) it would create a sterile environment for the fluid that is being used in the device and can also reseal the end of the device after needle usage to prevent leaking or contamination (¶[0047] from Reihl).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Grimard to include a self-sealing septum at the distal end of the body (¶[0047] from Reihl).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Grimard et al. (US 5,899,881) in view of Cherif-Cheikh et al. (US 2019/0255260).
Regarding claim 8, Grimard teaches a drug reservoir that can hold a drug (Col. 1 lines 39-56).
Grimard does not specifically teach the drug delivery device according to claim 7, wherein the drug reservoir comprises at least one of an insulin, and/or GLP-1 medicament.
Cherif-Cheikh teaches a device that can be used for the administration of two products during a single injection (abstract). Cherif-Cheikh teaches a plunger (Fig. 1a, 1) and a drug reservoir (Fig. 1a, 2). Cherif-Cheikh further teaches wherein the drug reservoir comprises an insulin and GLP-1 medicament (¶[0006] & [0166]). The device of Grimard allows for the use of different types of medicament to be used, but does not specify the type of medicament. Modifying the device of Grimard to use insulin and GLP-1 as the medicament that goes into the drug reservoir would not have any effect on the use or function of the device of Grimard as the device is designed to administer medicament. By modifying the device of Grimard to include insulin and GLP-1 medicament, it allows for the administration of two products in a single dose and gives the device a wider range of treatment because of the use of the drugs (¶[0006] & [0166] from Cherif-Cheikh).
Therefore, it would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify the device of Grimard to include insulin and GLP-1 medicaments in the drug reservoir (¶[0006] & [0166] from Cherif-Cheikh).
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 HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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