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 .
Drawings
The drawings were received on 12/18/2025. These drawings are acceptable.
Specification
The amendments to the Specification received on 12/18/2025 are acceptable.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 74 and 84 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 74 includes language that is now included in amended claim 64, and
Claim 84 includes language that is now included in amended claim 81.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 64, 66, 74-77, 81, and 83-87 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Wyss, US 8,734,396.
Regarding Claim 64
Wyss discloses a disease management device comprising:
a pump (not shown) configured to deliver fluid to an injection site of a patient (Wyss, Column 6, Lines 9-26);
one or more medication bladders (flexible container, 1) configured to store the fluid prior to delivery to the injection site of the patient (Wyss, Abstract, Column 6, Lines 9-26), each of the one or more medication bladders (1) comprising:
a rigid portion (2) coupled to a flexible portion (10, 11) to form an at least partially sealed enclosure (Wyss, Column 7, Lines 48-66), the rigid portion (2) comprising:
an outlet port (231) configured to allow an outward flow of the fluid from the at least partially sealed enclosure towards the pump (not shown), the outlet port (231) at a center of the rigid portion (2) (Wyss, Column 7, Line 62 – Column 8, Line 3); and
an interior surface (22) comprising a plurality of channels (221) configured to extend radially outward from the outlet port (231) to at least one edge of the rigid portion (2) (Wyss, Column 9, Lines 3-7, Figure 3A),
wherein the flexible portion (10, 11) comprises a flexible material configured to change shape so as to facilitate movement of the fluid within the at least partially sealed enclosure towards the outlet port (231) of the rigid portion (2) (Wyss, Column 5, Lines 37-48, Figures 4A and 4B).
Regarding Claim 66
Wyss discloses the disease management device of Claim 64, the rigid portion further comprising:
an inlet port (at (24, septum)) configured to facilitate access to the partially sealed enclosure for filling the one or more medication bladders (1) with the fluid (Wyss, Column 8, Lines 4-13, Figures 1C, 4A, and 6B).
Regarding Claim 74
Wyss discloses the disease management device of Claim 64, the rigid portion (2) further comprising:
an interior surface (22) comprising:
a plurality of channels (221) configured to extend from at least one edge of the rigid portion towards the outlet port (231) (Wyss, Column 9, Lines 3-7, Figure 3A).
Regarding Claim 75
Wyss discloses the disease management device of Claim 74. Wyss further discloses the rigid portion (2) further comprises one or more protrusions (segments of (22) between channels (221)) (Wyss, Figure 3A), wherein each channel (221) of the plurality of channels (221) forms a depression (recess) within a protrusion of the one or more protrusions, and wherein the depression (recess) is configured to facilitate movement of fluid within the at least partially sealed enclosure towards the outlet port (231) (Wyss, Column 5, Lines 37-48, Figures 4A and 4B).
Regarding Claim 76
Wyss discloses the disease management device of Claim 74. Wyss further discloses that the rigid portion (2) further comprises one or more guiding surfaces (225), including at least one of a curved surface or an inclined surface (Wyss, Column 9, Lines 3-16, Figure 3C),
wherein the one or more guiding surfaces (225) apply contours to the rigid portion (2) to facilitate the movement of fluid within the partially sealed enclosure towards the outlet port (231) of the rigid portion (2) (Wyss, Column 9, Lines 3-16, Figure 3C), and
wherein the plurality of channels (221) follow the contours of the rigid portion (2) (Wyss, Column 9, Lines 3-16, Figure 3C).
Regarding Claim 77
Wyss discloses the disease management device of Claim 74. Wyss further discloses that the flexible material of the flexible portion (10, 11) is configured to change shape at least by compressing against the plurality of channels (221) of the rigid portion (2) (Wyss, Figures 4A and 4B), wherein compression of the flexible material against the plurality of channels (221) of the rigid portion (2) facilitates the movement of fluid with the at least partially sealed enclosure towards the outlet port (231) of the rigid portion (2) (Wyss, Column 5, Lines 37-48, Figures 4A and 4B).
Regarding Claim 81
Wyss discloses a medication bladder (1, flexible container) comprising:
a rigid portion (2) coupled to a flexible portion (10, 11) to form an at least partially sealed enclosure (Wyss, Column 7, Lines 48-66), the rigid portion comprising:
an outlet port (231) configured to allow an outward flow of fluid from the at least partially sealed enclosure, the outlet port (231) at a center of the rigid portion (2) (Wyss, Column 7, Line 62 – Column 8, Line 3); and
an interior surface (22) comprising a plurality of channels (221) configured to extend radially outward from the outlet port (231) to at least one edge of the rigid portion (2) (Wyss, Column 9, Lines 3-7, Figure 3A),
wherein the flexible portion (10, 11) comprises a flexible material configured to change shape so as to facilitate movement of the fluid within the at least partially sealed enclosure towards the outlet port (231) of the rigid portion (2) (Wyss, Column 5, Lines 37-48, Figures 4A and 4B).
Regarding Claim 83
Wyss discloses the medication bladder of Claim 81, the rigid portion (2) further comprising: an inlet port (at (24, septum)) configured to facilitate access to the partially sealed enclosure for filling the medication bladder (1) with the fluid (Wyss, Column 8, Lines 4-13, Figures 1C, 4A, and 6B).
Regarding Claim 84
Wyss discloses the medication bladder of Claim 81, the rigid portion (2) further comprising: an interior surface (22) comprising: a plurality of channels (221) configured to extend from at least one edge of the rigid portion towards the outlet port (231) (Wyss, Column 9, Lines 3-7, Figure 3A).
Regarding Claim 85
Wyss discloses the medication bladder of Claim 84. Wyss further discloses the rigid portion (2) further comprises one or more protrusions (segments of (22) between channels (221)) (Wyss, Figure 3A), wherein each channel (221) of the plurality of channels (221) forms a depression (recess) within a protrusion of the one or more protrusions, and wherein the depression (recess) is configured to facilitate movement of fluid within the at least partially sealed enclosure towards the outlet port (231) (Wyss, Column 5, Lines 37-48, Figures 4A and 4B).
Regarding Claim 86
Wyss discloses the medication bladder of Claim 84. Wyss further discloses that the rigid portion (2) further comprises one or more guiding surfaces (225), including at least one of a curved surface or an inclined surface (Wyss, Column 9, Lines 3-16, Figure 3C),
wherein the one or more guiding surfaces (225) apply contours to the rigid portion (2) to facilitate the movement of fluid within the partially sealed enclosure towards the outlet port (231) of the rigid portion (2) (Wyss, Column 9, Lines 3-16, Figure 3C), and
wherein the plurality of channels (221) follow the contours of the rigid portion (2) (Wyss, Column 9, Lines 3-16, Figure 3C).
Regarding Claim 87
Wyss discloses the medication bladder of Claim 84. Wyss further discloses that the flexible material of the flexible portion (10, 11) is configured to change shape at least by compressing against the plurality of channels (221) of the rigid portion (2) (Wyss, Figures 4A and 4B), wherein compression of the flexible material against the plurality of channels (221) of the rigid portion (2) facilitates the movement of fluid with the at least partially sealed enclosure towards the outlet port (231) of the rigid portion (2) (Wyss, Column 5, Lines 37-48, Figures 4A and 4B).
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) 65 and 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyss, US 8,734,396, in view of Kessel, WO 2022/198202 A1.
Regarding Claim 65
Wyss discloses the disease management device of claim 64,
wherein the rigid portion (2) further comprises a first interior surface (Wyss, Figures 1C and 4A), and
wherein the flexible portion (10, 11) further comprises a second interior surface (Wyss, Figures 1C and 4A), and
wherein the second interior surface further comprise a metalized film or a silicon oxide or aluminum oxide coating to improve barrier properties (Wyss, Column 5, Lines 54-56).
However, Wyss does not explicitly disclose that the first interior surface and second interior surface further comprise an anti-aggregation coating, wherein the anti-aggregation coating facilitates the movement of fluid within the at least partially sealed enclosure towards the outlet port of the rigid portion.
Kessel teaches a disease management device comprising: a rigid portion (9502, 9508) further comprising a first interior surface (Kessel, [0136]), and
a flexible portion (9516) further comprising a second interior surface (interior volume facing surface of the reservoir film (9516)) (Kessel, [0136]-[0137]),
and wherein the first interior surface and second interior surface (interior volume facing surface of the reservoir film (9516)) further comprise an anti-aggregation coating (Cyclic Olefin Polymer (COP) or Cyclic Olefin Copolymer (COC), Cyclic Olefin Polymer (COP)) (Kessel, [0136]-[0137]), wherein the anti-aggregation coating facilitates the movement of fluid within the at least partially sealed enclosure (9536) towards the outlet port (9580) of the rigid portion (9502, 9508) (Kessel, [0136]-[0137]).
[Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer (COC) are long term drug compatible materials that minimize reactions with the fluid, thereby facilitating movement of the fluid within the at least partially sealed enclosure towards the outlet port of the rigid portion.]
At the time the claimed invention was filed it would have been obvious to one of ordinary skill in the art to provide anti-aggregation coating on the first and second interior surfaces of Wyss since this would provide the advantage of increase fluid movement as taught by Kessel.
Regarding Claim 82
Wyss discloses the medication bladder of Claim 81:
wherein the rigid portion (2) further comprises a first interior surface (Wyss, Figures 1C and 4A), and
wherein the flexible portion (10, 11) further comprises a second interior surface (Wyss, Figures 1C and 4A), and
wherein the second interior surface further comprise a metalized film or a silicon oxide or aluminum oxide coating to improve barrier properties (Wyss, Column 5, Lines 54-56).
However, Wyss does not explicitly disclose that the first interior surface and second interior surface further comprise an anti-aggregation coating, wherein the anti-aggregation coating facilitates the movement of fluid within the at least partially sealed enclosure towards the outlet port of the rigid portion.
Kessel teaches a disease management device comprising: a rigid portion (9502, 9508) further comprising a first interior surface (Kessel, [0136]), and
a flexible portion (9516) further comprising a second interior surface (interior volume facing surface of the reservoir film (9516)) (Kessel, [0136]-[0137]),
and wherein the first interior surface and second interior surface (interior volume facing surface of the reservoir film (9516)) further comprise an anti-aggregation coating (Cyclic Olefin Polymer (COP) or Cyclic Olefin Copolymer (COC), Cyclic Olefin Polymer (COP)) (Kessel, [0136]-[0137]), wherein the anti-aggregation coating facilitates the movement of fluid within the at least partially sealed enclosure (9536) towards the outlet port (9580) of the rigid portion (9502, 9508) (Kessel, [0136]-[0137]).
[Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer (COC) are long term drug compatible materials that minimize reactions with the fluid, thereby facilitating movement of the fluid within the at least partially sealed enclosure towards the outlet port of the rigid portion.]
At the time the claimed invention was filed it would have been obvious to one of ordinary skill in the art to provide anti-aggregation coating on the first and second interior surfaces of Wyss since this would provide the advantage of increase fluid movement as taught by Kessel.
Allowable Subject Matter
Claims 69, 79-80, and 88-90 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In the disease management device of claim 69, the inclusion of:
“the disease management device further comprises a plunger configured to apply external pressure to at least one of the one or more medication bladders” was not found.
In the disease management device of claim 79, the inclusion of:
“a central region including the outlet port;
a top surface; and
one or more protruding structures,
wherein the one or more protruding structures extend vertically with respect to a major plane of the top surface,
wherein the one or more protruding structures extend from the at least of the one or more walls or one or more edges to the central region” was not found.
In the medication bladder of claim 88, the inclusion of:
“a central region including the outlet port;
a top surface; and
one or more protruding structures,
wherein the one or more protruding structures extend vertically with respect to a major plane of the top surface,
wherein the one or more protruding structures extend from the at least of the one or more walls or one or more edges to the central region” was not found.
Response to Arguments
Applicant’s arguments, with respect to the Objections to the Drawings, Claims, and Specification have been fully considered and are persuasive. The Drawing, Claim, and Specification objections have been withdrawn. Applicant’s arguments, with respect to the claim interpretation under 35 U.S.C. 112(f) have been fully considered and are persuasive. The claim interpretation under 35 U.S.C. 112(f) has been withdrawn.
Applicant’s arguments with respect to claim(s) 64-66, 74-77, and 81-87 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, the Applicant’s amendments to the claim have initiated a new ground(s) of rejection under 35 U.S.C. 102(a)(1) an 35 U.S.C. 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Barnes (US 11,660,389)
Cardinali (US 11,229,736)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L STANEK whose telephone number is (571)272-3565. The examiner can normally be reached Mon - Fri 8:30am-3:00pm.
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/K.L.S/Examiner, Art Unit 3746 2/24/2026
/DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741