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 .
Election/Restrictions
Applicant's election of Species A and B in the reply filed on 10/14/2025 is acknowledged. Applicant argues that Species A drawn to figs. 3 and 4, and Species B as drawn to figs. 5A-5D as indicated by the examiner are drawn to the same embodiment. This argument is convincing. Therefore, the restriction between Species A and Species B is withdrawn and the Examiner accepts Applicant’s election of these two Species. Applicant has not otherwise traversed the restriction requirement as drawn to Species C and D.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 11 is objected to because of the following informalities: claim 11, lines 2-3 recite, “causing a breakable membrane… to break such a passage is formed…”. This should read – such that a passage is formed. Appropriate correction is required.
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) 1, 2, 6-8, 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sancoff et al (US 5,571,261).
Regarding claim 1, Sancoff discloses an activatable medicament delivery container (figs. 3-6) comprising: a body 4 comprising an inner surface defining a medicament chamber 24, an expansion chamber 36, and an activation chamber (surrounded by container 30; fig. 3; col. 10, lines 43-46; col. 12, lines 9-12); a medicament port 28 forming a passage fluidly coupled with the medicament chamber (fig. 4; col. 9, lines 46-47); a pressure membrane 18 that fluidly separates medicament chamber 24 and the expansion chamber 36 (fig. 3; col. 11, lines 3-7); and a breakable membrane (figs. 3, 4: portion of wall 30 between chamber 36 and chamber within 30; col. 12, lines 28-18-20) comprising a first configuration wherein the breakable membrane fluidly separates the expansion chamber and the activation chamber (fig. 3), and a second configuration wherein the breakable membrane forms a passage 50 between the expansion chamber and the activation chamber (fig. 4); wherein, when the breakable membrane is in the second configuration, an activator material 38 within the activation chamber can contact an expandable material 40 within the expansion chamber through the passage (fig. 4), such that a volume of the expansion chamber increases, thereby displacing a pressure membrane toward the medicament chamber to increase a pressure therein (fig. 5; col. 12, lines 8-15).
Regarding claim 2, Sancoff discloses that when a pressure increases within the medicament chamber, a medicament is directed out of the medicament chamber through the medicament port (fig. 5; col. 9, lines 45-47).
Regarding claim 6, Sancoff discloses that the pressure membrane 18 comprises a surface area that is larger than an area in which the medicament chamber and the pressure chamber are intersected by the pressure membrane (see fig. 3 annotated below).
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Regarding claim 7, Sancoff discloses that the pressure membrane comprises a stretchable material (col. 10, lines 36-40: minimal elasticity implies an amount of stretchability), such that the pressure membrane can have a first surface area in a first configuration and stretch to have a second surface area in a second configuration, wherein the second surface area is larger than the first surface area (fig. 5).
Regarding claim 8, Sancoff discloses that the pressure membrane and the breakable membrane are contiguous (fig. 4: contiguous via housing wall 8).
Regarding claim 10, Sancoff discloses that the activation chamber comprises an activation material 38, the activation material comprising a water (col. 11, lines 53-55: activation chemical may be dispersed in water and therefore the activation material includes the chemical and water).
Regarding claim 11, Sancoff discloses a method of delivering a medicament from an activatable medicament delivery container (col. 5, lines 55-57; figs. 3-6), the method comprising causing a breakable membrane (fig. 4: membrane at distal end of 30), which fluidly separates an expansion chamber 36 from an activation chamber (fig. 3: chamber within 30), to break such that a passage 50 is formed between the expansion chamber and the activation chamber (fig. 4), and an activator material 38 within the activation chamber contacts an expandable material 40 within the expansion chamber through the passage (fig. 4; col. 11, lines 19-25), wherein, contact between the activator material and the expandable material cause a volume of the expansion chamber to increase such that a pressure membrane 18 fluidly separating a medicament chamber from the expansion chamber is displaced toward the medicament chamber (fig. 5), thereby increasing a pressure within the medicament chamber and directing a medicament out of the medicament chamber through a medicament port 28 (fig. 5; col. 8, lines 28-32; col. 10, lines 42-45; col. 11, lines 3-11, 20-25; col. 12, lines 18-20).
Regarding claim 12, Sancoff discloses that breaking the breakable membrane comprises squeezing the activation chamber (col. 12, lines 24-26).
Regarding claim 13, Sancoff discloses directing the medicament out of the medicament chamber at a first rate by breaking the breakable membrane of a first activation chamber (col. 12, lines 8-15).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sancoff in view of McKechnie et al (US WO 02/087976 A2).
Regarding claim 9, Sancoff disclose that the expansion chamber comprises an expandable material 40 (col. 12, lines 9-15; fig. 5), but fails to discloses that the expandable material comprises an expandable polymer. McKechnie teaches a delivery system including an expansion chamber and a delivery chamber separated by a membrane 5 (page 13, lines 20-24; fig. 1), the expansion chamber comprising an expandable material comprising an expandable polymer that applies pressure to the membrane upon activation (page 2, lines 1-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable material of Sancoff to be an expandable polymer as taught by McKechnie to provide the force to expel the drug from the container in a reliable manner and to provide a solid expansion material that will not leak out of the device should the membrane become damaged.
Allowable Subject Matter
Claims 3-5, 14 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: Regarding claim 3, the prior art fails to teach or fairly suggest the body comprising a first activation chamber and a second activation chamber that is fully separated from the first activation chamber, in combination with the features of the invention, substantially as claimed.
Regarding claim 14, the prior art fails to teach or fairly suggest a method including the step of breaking a breakable membrane of a second activation chamber, in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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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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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783