DETAILED ACTION
CLAIM INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘proximal cage portion’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
Claim Objections
Claims 3, 10-12, 18 and 19 are objected to because of the following informalities:
Claim 3, line 7, before “expand”, please insert --configured to--.
Claim 3, line 8, before “expand”, please insert --configured to--.
Claim 10, line 1, after “3”, please insert --, --.
Claim 11, line 1, after “3”, please insert --, --.
Claim 12, line 7, before “expand”, please insert --configured to--.
Claim 12, line 8, before “expand”, please insert --configured to--.
Claim 18, line 1, after “12”, please insert --, --.
Claim 19, line 7, before “expand”, please insert --configured to--.
Claim 19, line 8, before “expand”, please insert --configured to--.
Appropriate correction is required.
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.
Claim(s) 12-15, 19-21, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul, JR (US 2011/0166593A1, “Paul”) in view of Jones et al. (US 2012/0330342A1, “Jones”).
Regarding claims 12, 14, 15, 19, 21, and 25, Paul discloses a system including a cage (112; Fig. 3; [0025, 0038]) including a proximal cage portion having proximal strut portions and a distal cage portion including distal strut portions. A shape memory foam (34, 134; [0028, 0036]) that is capable of expanding when transitioning from an unactuated configuration to an actuated configuration. The foam is a cylindrical rod placed within the cage that is capable of expanding to occupy substantially the entire interior of the device (10, 110) in the actuated configuration [0028]. The proximal and distal strut portions include a shape memory material, e.g. nitinol [0037]. The proximal strut portions are configured to expand from a first proximal configuration to a second proximal configuration and the distal strut portions are configured to expand from a first distal configuration to a second distal configuration (Fig. 3; please see annotated figure below). The second proximal configuration and second distal configuration has a larger maximum outer diameter than the first proximal configuration and first distal configuration (Fig. 3). The foam, having a cylindrical rod shape, in the unactuated configuration, is capable of being included within a proximal space defined by the proximal strut portions when the proximal strut portions are in the second proximal configuration. The foam, having a cylindrical rod shape, in the unactuated configuration, is capable of being included within a distal space defined by the distal strut portions when the distal strut portions are in the second distal configuration. The foam is not fixedly and directly connected to either of the proximal or distal strut portions and is expandable from the unactuated configuration to the actuated configuration independently from either of the proximal or distal strut portions. The foam, having a cylindrical rod shape, in the unactuated configuration, the proximal strut portions are in the first proximal configuration and the distal strut portions are in the first distal configuration (Fig. 3). However, Paul does not disclose an expandable foam formed of shape memory polymer.
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In the same field of endeavor, occlusion devices, Jones teaches an expandable foam formed of shape memory polymer [0029] that is disposed within a cage (120; Fig. 3). The foam may be formed of electroactive polymers which are independently actuated by exposure to electric fields. The foam, having a rod shape, in both unactuated and actuated configurations is included within the proximal space and distal space, respectively defined by proximal and distal strut portions in the second configurations. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the expandable shape memory foam of Paul with the polymeric material of the expandable shape memory foam, as taught by Jones, as this modification involves the simple substitution of one expandable foam for another for the predictable result of occluding the lumen of the cage.
Regarding claims 13 and 20, the combination of Paul and Jones discloses that the SMP foam is monolithic and at least one of the proximal strut portions is monolithic and integral with at least one of the distal strut portions [0028; Paul; Fig. 3].
Allowable Subject Matter
Claims 16-18 and 22-24 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.
Claim(s) 3-11 allowed. Regarding claim 3, the prior art of record does not disclose or suggest a system including a cage having a proximal cage portion including proximal strut portions and a distal cage portion including distal strut portions, a shape memory polymer (SMP) foam, the SMP foam is included within a proximal space defined by the proximal strut portions when the proximal strut portions are in a second proximal configuration which has a larger maximum outer diameter than a first proximal configuration, the SMP foam is not fixedly and directly connected to either the proximal or distal strut portions and is expandable from an unactuated configuration to an actuated configuration independently from either of the proximal or distal strut portions, in the second proximal configuration the proximal strut portions form an expanded proximal cage portion and in the second distal configuration the distal strut portions form an expanded distal cage portion, the SMP foam extends radially from within at least one of the expanded proximal or distal cage portions to outside and beyond the at least one of the expanded proximal or distal cage portions in the actuated configuration, the SMP foam is in the unactuated configuration when the proximal strut portions are in the first proximal configuration and the distal strut portions are in the first distal configuration, in combination with the other claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wilson et al. (US 2011/0144686A1) discloses a SMP foam device used for occlusion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/ Primary Examiner, Art Unit 3771
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