DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The examiner acknowledges the reply filed on 04/13/2026 in which no claims were amended. Currently, claims 1-18 are pending for examination in this application.
Terminal Disclaimer
The terminal disclaimer, filed on 04/13/2026, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 11,491,273, has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments, filed 04/13/2026, have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The examiner has fully considered the applicant’s arguments but they are not persuasive. It is the examiner’s position that given a careful reading, the claims do not distinguish over the prior art of record.
With regards to claim 1, applicant’s representative asserts the prior art to Radmer fails to teach “a depression formed in the body within an area surrounded by the attachment area” and “a movable wall attached to the body at the attachment area so as to define with the body a reservoir space to hold the liquid.” The examiner respectfully disagrees. First, the examiner notes applicant’s representative’s remarks states that there “is no depression formed by the housing member, it is a hole instead.” The argument fails to provide any distinction as to how a “hole” could not be considered to be “depression” formed in the body. Given the broadest reasonable interpretation, a “depression” merely implies an area which is lower in topography than its surroundings. Even a structure deemed to be a “hole” would meet this definition. Furthermore, the examiner has pointed to item 260 (“bag-like drug reservoir”) as meeting the limitation of “a movable wall attached to the body at the attachment area so as to define with the body a reservoir space to hold the liquid.” As noted in the standing the rejection, the examiner has indicated the “attachment area” as the location of attachment between item 255 (portion of the body) and item 260 (movable wall). At present, the claim language merely requires the depression (location of the septum 261) be formed within the body (the depression is formed within item 255) within an area surrounded by the attachment area. Applicant’s representative’s arguments relative to a “hole” versus a “depression” fail to address the rejection presented by the examiner. As such, the examiner finds applicant’s representative’s arguments unconvincing and the rejection is maintained.
With regards to claim 2, applicant’s representative asserts the prior art to Radmer fails to teach “wherein the reservoir is arranged to provide the liquid in the reservoir space from the fluid channel based on negative pressure applied to the fluid channel provided by the infusion device.” Again, the examiner respectfully disagrees. As noted in the standing rejection, the claim limitations relative to applicant’s representative’s arguments are functional in nature. As such, the examiner would remind applicant’s representative that the currently recited claims are drawn to an apparatus, rather than method steps. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Applicant’s representative’s arguments fail to show how the structure taught by Radmer could not meet the recited functional limitation if negative pressure were to be applied to the fluid channel. Again, applicant’s representative’s arguments are unconvincing and the rejection is maintained.
With regards to claim 3, applicant’s representative asserts the prior art to Radmer fails to teach “wherein, in a filled state in which the reservoir space is at a maximum volume, the reservoir is pressurized to ambient pressure.” The examiner respectfully disagrees. Applicant’s representative’s arguments are based upon the pressure in the drug reservoir during delivery by the Radmer device. However, the currently recited claim language merely requires “in a filled state in which the reservoir space is at a maximum volume.” The reservoir space taught by Radmer would meet this functional limitation prior to delivery. As such, applicant’s representative’s arguments are unconvincing and the rejection is maintained.
With regards to claim 10, applicant’s representative asserts the prior art to Radmer fails to teach “wherein the portion of the movable wall is movable to contact the body in a dispensed state.” Again, the examiner respectfully disagrees. First, the examiner would note that the currently recited claim limitations argued by applicant’s representative are once again functional in nature. The examiner would also note that the claim limitations do not prevent the movable wall from always being in contact with the body (either in a full or dispensed state). As the examiner has pointed to items 230/255 as meeting the limitation of “the body,” the movable wall taught by Radmer (item 260) is always in contact with the body. Once again, applicant’s representative’s arguments are unconvincing and the rejection is maintained.
With regards to claim 11, applicant’s representative asserts the prior art to Radmer fails to teach “wherein the portion of the movable wall is movable to contact the body and collapse the reservoir space.” Again, the examiner respectfully disagrees. As with the limitations of claim 10, applicant’s representative’s arguments are once again functional in nature. Again, the examiner would also note that the claim limitations do not prevent the movable wall from always being in contact with the body (either in a full or dispensed state). As the examiner has pointed to items 230/255 as meeting the limitation of “the body,” the movable wall taught by Radmer (item 260) is always in contact with the body. Further, as best understood by the examiner, it appears applicant’s representative is arguing that contact with the body must be what causes the collapse of the reservoir space in order to meet the claim limitations. However, as currently recited, the claim limitations merely require that the movable wall is capable of collapse. As such, Radmer meets this functional limitation. Given this, applicant’s representative’s arguments are unconvincing and the rejection is maintained.
In light of the remarks and standing rejection above, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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 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 pre-AIA 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 –
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
Claims 1-18 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Radmer et al. (PGPub 2007/0049865).
[Claims 1, 5, and 13] Radmer teaches a reservoir (figure 23a, item 250) for use with an infusion device arranged to provide a liquid to a user (paragraph [0091]), the reservoir comprising:
a rigid body (figure 23a, items 230/255) (paragraph [0098]) defining a fluid channel (figure 23a, item 213) and an attachment area (location of attachment between items 255 and 260), a depression (location of septum 261) formed in the body (figure 23a, items 230/255) within an area surrounded by the attachment area (location of attachment between items 255 and 260) and a neck element (figure 23a, item 222 and top portion of item 255) that extends from the body (figure 23a, items 230/255) including a portion (figure 23a, item 214) of the fluid channel (figure 23a, item 213) therein;
a movable wall (figure 23a, item 260) attached to the body (figure 23a, items 230/255) at the attachment area (location of attachment between items 255 and 260) so as to define with the body (figure 23a, items 230/255) a reservoir space to hold the liquid (space within bag 260; paragraph [0098]), a portion of the movable wall (figure 23a, item 260) being movable (“bag-like”) relative to the body (figure 23a, items 230/255) to adjust a volume of the reservoir space (paragraph [0098]); and
a piercable member (septum) (figure 23a, item 261) positioned to prevent flow through the fluid channel (figure 23a, item 213) (figure 23a; paragraph [0098]),
wherein the fluid channel (figure 23a, item 213) is the only fluid passageway into or out of the reservoir space (space within bag 260) (figures 23a and 23b).
[Claims 2-4] Radmer teaches the limitations of claim 1, upon which claims 2-4 depend. In addition, Radmer discloses the reservoir (figure 23a, item 250) is
arranged to provide the liquid in the reservoir space (space within bag 260) from the fluid channel (figure 23a, item 213) based on negative pressure applied to the fluid channel (figure 23a, item 213) provided by the infusion device (the examiner notes the structure taught by Radmer is capable of meeting this functional limitation);
wherein, in a filled state in which the reservoir space (space within bag 260) is at a maximum volume (figure 23a), the reservoir is pressurized to ambient pressure (figure 23a; the bag 260 is functionally capable of meeting these limitations);
wherein the reservoir (figure 23a, item 250) is arranged to receive liquid into the reservoir space (space within bag 260) through the piercable member (figure 23a, item 261) and to provide liquid from the space (space within bag 260) through the piercable member (figure 23a, item 261) in a pierced state (figure 23b).
[Claims 6 and 8-11] Radmer teaches the limitations of claim 1, upon which claims 6 and 8-11 depend. Radmer further discloses the movable wall (figure 23a, item 260) is
a piece of flexible material attached to the body (figure 23a, items 230/255) (paragraph [0098]);
arranged such that movement of the movable wall (figure 23a, item 260) toward (the examiner notes the claim language does not require movement relative to any particular portion of the fluid channel) the fluid channel (figure 23a, item 213) decreases the volume of the reservoir space (space within bag 260) (figures 23a and 23b);
arranged such that movement of the portion of the movable wall (figure 23a, item 260) in a direction transverse (the examiner notes the claim language does not require “transverse” movement relative to any particular portion of the fluid channel) to the fluid channel (figure 23a, item 213) decreases the volume of the space (space within bag 260) (figures 23a and 23b);
wherein the portion of the movable wall (figure 23a, item 260) is movable to contact the body (figure 23a, items 230/255) in a dispensed state and collapse the reservoir space (figure 23b).
[Claim 7] Radmer teaches the limitations of claim 1, upon which claim 7 depends. Radmer further discloses the attachment area (location of attachment between items 255 and 260) has an annular shape and the piece of flexible material (figure 23a, item 260) has a generally circular shape (figures 23a and 23b).
[Claim 12] Radmer teaches the limitations of claim 1, upon which claim 12 depends. Radmer also teaches a port opening (connection to the fluid channel at item 214) disposed in the neck element (figure 23a, item 222 and top portion of item 255), the neck element (figure 23a, item 222 and top portion of item 255) at least partially extends (figure 23a) from a side of the body (figure 23a, items 230/255) opposite to a side where the movable wall (figure 23a, item 260) is attached to the body (figure 23a, items 230/255), and wherein the port opening (connection to the fluid channel at item 214) is in fluid communication with the fluid channel (figure 23a, item 213).
[Claims 14-16] Radmer teaches the limitations of claim 1, upon which claims 14-16 depend. Radmer further discloses the neck element (figure 23a, item 222 and top portion of item 255) defines a receiving chamber (space created by the needle piercing the septum) to receive an end of a piercing element (figure 23a, item 214) that pierces the piercable member (figure 23a, item 261) to receive the liquid from the reservoir space (space within bag 260); wherein the receiving chamber (space created by the needle piercing the septum) is positioned between the piercable member (figure 23a, item 261) and the reservoir space (space within bag 260) and is adapted to receive the end of the piercing element (figure 23a, item 214) upon piercing of the piercable member (figure 23a, item 261) (figure 23b).
[Claims 17 and 18] Radmer teaches the limitations of claim 1, upon which claims 17 and 18 depend. In addition, Radmer teaches the piercable member (figure 23a, item 261) includes a piercable plug (“elastomeric septum”) located in the neck element (figure 23a, item 222 and top portion of item 255) that closes the fluid channel (figure 23a, item 213) to fluid flow (figure 23a) and is piercable to provide fluid access to the reservoir space (space within bag 260) (figure 23b) (paragraph [0098]).
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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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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.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 06/22/2026
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