DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 05/14/2024, has been considered by the examiner.
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]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-36 of U.S. Patent No. 11,491,273. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 1 of the instant application can be found in claim 19 of the patent. The difference between claim 1 of the instant application and claim 19 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 19 of the patent is in effect a “species” of the "generic” invention of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 19 of the patent, it is not patentably distinct from claim 19 of the patent.
Conclusion
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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/JASON E FLICK/Primary Examiner, Art Unit 3783 12/04/2025