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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation “through the septum into the housing, preferably into the reservoir” renders the claim indefinite. It is unclear whether the limitation after preferably is positively recited. In an effort to compact prosecution, the limitation is interpreted as --through the septum into the housing--.
Claim 8 recites the limitation “the polymer preferably comprises a polyhalogenated olefin, a silicone, or a thermoplastic elastomer” renders the claim indefinite. It is unclear whether the limitation after preferably is positively recited. In an effort to compact prosecution, the limitation is interpreted as -- the polymer comprises a polyhalogenated olefin, a silicone, or a thermoplastic elastomer--.
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)(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, 7-8, 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelsen (US 6013051).
Regarding claim 1, Nelsen discloses an implant (figure 7) for the sustained subcutaneous release of an active ingredient, comprising a housing (8, 4, and 22), which is delimited on a first side by a septum (8, figure 7, col 3, lines 15-20) and comprises an outlet (opening formed by 40 and 50) on a second side for the release of an active ingredient, and a reservoir (10, col 4, lines 35-41), which is arranged in a cavity (cavity formed by 4) of the housing and is designed to receive a liquid containing an active ingredient (col 4, lines 35-41).
Regarding claim 2, Nelsen discloses wherein the implant further comprises an anti-piercing means (14, col 5, lines 1-10) within the housing which, together with a wall (lower portion 12) of the housing, defines a channel (18), wherein the channel is designed to guide active ingredient from the reservoir to the outlet (18 exits through 50, col 5, lines 1-10).
Regarding claim 3, Nelsen further discloses wherein the anti-piercing means comprises a surface structure (wall of 14 is a surface structure) which defines a distance of the anti-piercing means from the reservoir and/or from the housing (surface structures define a distance to other structures).
Regarding claim 7, Nelsen discloses wherein the reservoir is arranged within the housing and is designed to allow free circulation of a liquid containing an active ingredient between the septum and the outlet (col 4, lines 35-41).
Regarding claim 8, Nelsen discloses wherein the septum comprises a flexible, self-sealing polymer (col 3, lines 30-37) wherein the polymer comprises a polyhalogenated olefin, a silicone, or a thermoplastic elastomer (silicone rubber).
Regarding claim 10, Nelsen discloses wherein the septum is designed to expand resiliently when a liquid is injected into the cavity of the housing (silicone rubber expands resiliently, col 3, lines 30-37).
Regarding claim 11, Nelsen discloses wherein the second side of the housing comprises a substantially planar shape (figure 2).
Regarding claim 12, Nelsen discloses wherein the inner diameter of the outlet determines the delivery rate of an active ingredient from the reservoir (outlet of 40 or 50 determines the flow rate since it’s the only exit).
Regarding claim 13, Nelsen discloses which further comprises a fastening element (6) designed to be connected to body tissue (figure 5 and 8 shows that 65 is on a tissue).
Regarding claim 14, Nelsen discloses wherein the reservoir is filled with a liquid containing an active ingredient (col 4, lines 35-41).
Regarding claim 15, Nelsen discloses the device which is designed, in a subcutaneously implanted state, to be filled with a liquid containing an active ingredient by injecting the liquid through the septum into the housing (col 4, lines 35-41).
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vogt (US 2022/0105325 effectively filed Oct 2, 2020).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Vogt discloses an implant (figure 9) for the sustained subcutaneous release of an active ingredient, comprising a housing (31 and 2), which is delimited on a first side by a septum (31, [0144]) and comprises an outlet (3, [0145]) on a second side for the release of an active ingredient, and a reservoir (35, [0146]), which is arranged in a cavity of the housing and is designed to receive a liquid containing an active ingredient ([0001]).
Regarding claim 2, Vogt discloses wherein the implant further comprises an anti-piercing means (6, [0149]) within the housing which, together with a wall (wall 2) of the housing, defines a channel (34), wherein the channel is designed to guide active ingredient from the reservoir to the outlet (34 and 6 forms a passageway which only has 3 as the exit, figure 12).
Regarding claim 3, Vogt further discloses wherein the anti-piercing means comprises a surface structure ([0067]) which defines a distance of the anti-piercing means from the reservoir and/or from the housing (surface structures define a distance to other structures).
Regarding claim 7, Vogt discloses wherein the reservoir is arranged within the housing and is designed to allow free circulation of a liquid containing an active ingredient between the septum and the outlet ([0174-0175]).
Regarding claim 8, Vogt discloses wherein the septum comprises a flexible, self-sealing polymer ([0144]), wherein the polymer comprises a polyhalogenated olefin, a silicone, or a thermoplastic elastomer ([0144]).
Regarding claim 9, Vogt discloses wherein the septum comprises a convexly curved shape (figure 14).
Regarding claim 10, Vogt discloses wherein the septum is designed to expand resiliently when a liquid is injected into the cavity of the housing ([0039]).
Regarding claim 11, Vogt discloses wherein the second side of the housing comprises a substantially planar shape (figure 15).
Regarding claim 12, Vogt discloses wherein the inner diameter of the outlet determines the delivery rate of an active ingredient from the reservoir ([0152]).
Regarding claim 13, Vogt discloses which further comprises a fastening element (50) designed to be connected to body tissue ([0161]).
Regarding claim 14, Vogt discloses wherein the reservoir is filled with a liquid containing an active ingredient ([0001]).
Regarding claim 15, Vogt discloses the device which is designed, in a subcutaneously implanted state, to be filled with a liquid containing an active ingredient by injecting the liquid through the septum into the housing ([0152], [0161]).
Claim Rejections - 35 USC § 103
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 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) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Nelsen in view of Gaserod (US 9028872).
Regarding claims 4-6, Nelsen does not disclose wherein the reservoir comprises an open-pore material (claim 4), wherein the reservoir comprises reticulated foam, sintered plastics particles, pressed plastics fibers, pressed natural fibers, or bonded plastics fibers (claim 5), wherein the reservoir comprises a crosslinked salt of polyacrylic acid, a crosslinked polyacrylamide, a salt of a crosslinked polystyrene sulfonic acid, a polysaccharide, or a polysaccharide derivative (claim 6).
Gaserod discloses an implant polysaccharide gel for controlled release delivery systems relatively pertinent to problem raised by Applicant of releasing liquid into the body and teaches the reservoir comprises an open-pore material (col 1, lines 8-15)), wherein the reservoir comprises reticulated foam, sintered plastics particles, pressed plastics fibers, pressed natural fibers, or bonded plastics fibers (col 2, lines 60-67), wherein the reservoir comprises a crosslinked salt of polyacrylic acid, a crosslinked polyacrylamide, a salt of a crosslinked polystyrene sulfonic acid, a polysaccharide, or a polysaccharide derivative (col 1, lines 8-15, col 9, lines 45-67).
Gaserod provides a composition in order to control the rate of release of material from the gel (col 12, lines 50-col 13, lines 1-5). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Nelsen with the composition of Gaserod to control the release of material from the composition and thus further control the release of active ingredient from the implant.
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Vogt in view of Gaserod (US 9028872).
Regarding claims 4-6, Vogt does not disclose wherein the reservoir comprises an open-pore material (claim 4), wherein the reservoir comprises reticulated foam, sintered plastics particles, pressed plastics fibers, pressed natural fibers, or bonded plastics fibers (claim 5), wherein the reservoir comprises a crosslinked salt of polyacrylic acid, a crosslinked polyacrylamide, a salt of a crosslinked polystyrene sulfonic acid, a polysaccharide, or a polysaccharide derivative (claim 6).
Gaserod discloses an implant polysaccharide gel for controlled release delivery systems relatively pertinent to problem raised by Applicant of releasing liquid into the body and teaches the reservoir comprises an open-pore material (col 1, lines 8-15)), wherein the reservoir comprises reticulated foam, sintered plastics particles, pressed plastics fibers, pressed natural fibers, or bonded plastics fibers (col 2, lines 60-67), wherein the reservoir comprises a crosslinked salt of polyacrylic acid, a crosslinked polyacrylamide, a salt of a crosslinked polystyrene sulfonic acid, a polysaccharide, or a polysaccharide derivative (col 1, lines 8-15, col 9, lines 45-67).
Gaserod provides a composition in order to control the rate of release of material from the gel (col 12, lines 50-col 13, lines 1-5). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Vogt with the composition of Gaserod to control the release of material from the composition and thus further control the release of active ingredient from the implant.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nelsen.
Regarding claim 9, Nelsen does not disclose wherein the septum comprises a convexly curved shape.
However, it has been held that a mere change in shape and size is an obvious variant over the prior art of record (MPEP 2144). In this case, making the septum convex shape does not impact the overall functionality and would not require any undue experimentation for the septum to continue to have the desired material characteristic. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Nelsen to change the shape of the septum in order to continue to inject drug into the implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Christian (US 10130803)- discloses a convex septum for implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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/KAI H WENG/Primary Examiner, Art Unit 3781