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 .
Election/Restrictions
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5 December 2025. The examiner acknowledges the cancellation of non-elected claims 12-20.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 3, 4, and 8 are objected to because of the following informalities:
Claim 3: “the one or more and second first overhangs” should read --the one or more first and second overhangs--
Claim 4: “translates” should read --transforms-- for consistency with parent claim 1
Claim 8: “allot” should read --alloy--
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-4 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2010/0131006 (Chanduszko).
Regarding claim 1, Chanduszko teaches a three-dimensional (3D) hernia plug (30) (abstract; The limitation “hernia plug” is intended use. Since the plug of Chanduszko is configured and employed for closing an aperture in a body organ, the plug is capable of performing the claimed intended use, [0018], Figure 5), comprising: a waist portion (36, 38) extending, along a longitudinal extension axis, between a first waist end and a second waist end; one or more first overhangs (32a-32c) coupled to the first waist end; and one or more second overhangs (34a-34c) coupled to the second waist end, wherein the hernia plug is configured to transform between a pre-activation state and a post-activation state (shape memory: [0008], [0018]-[0019], “pre-activation state” shown in Figure 1 and “post-activation state” shown in Figures 2-4; [0024]; Figures 3-4).
Regarding claims 2-4 and 6-8, Chanduszko teaches the hernia plug (30) is configured to change shape between the pre-activation state and a post-activation state; wherein in the pre-activation state, each of the one or more first and second overhangs (32a-32c, 34a-34c) extends substantially parallel to the extension axis, and in the post-activation state, each of the one or more first and second overhangs extends substantially orthogonal to the extension axis; wherein the hernia plug translates from the pre-activation state to the post-activation state in response to a thermal stimuli; wherein the hernia plug is manufactured from a smart memory material; wherein the thermal stimuli corresponds to the glass transition temperature (Tg) of the smart memory material; wherein the smart material polymer comprises a shape memory alloy ([0018]-[0019]; [0021]; nitinol, [0035]; Figures 1-3).
Regarding claim 9, Chanduszko teaches the hernia plug (30) is deployable at a hernia-defect site in the post-activated state, the hernia-defect site comprising an inguinal hernia-defect side, and the one or more first overhangs are configured to engage a groin-side of an abdominal wall, and the one or more second overhangs are configured to engage an abdomen-side of the abdominal wall, such that the hernia plug is self-gripping (The limitation “deployable at a hernia-defect site in the post-activated state, the hernia-defect site comprising an inguinal hernia-defect side, and the one or more first overhangs are configured to engage a groin-side of an abdominal wall, and the one or more second overhangs are configured to engage an abdomen-side of the abdominal wall, such that the hernia plug is self-gripping” is functional language. Since the plug 30 of Chanduszko is configured for insertion into a defect in a body organ in a first state, and to transform to a second state to anchor its overhangs on either side of the defect of the body organ, the plug 30 is capable of performing the claimed function. See “anchoring”, [0007], [0018], [0024]-[0025], and Figures 1-5).
Regarding claim 10, Chanduszko teaches each of the one or more first and second overhangs (32a-32c, 34a-34c) comprises one of a planar member and a rod-like elongate member, and the waist portion (36, 38) comprises one of, (i) one or more connected continuous members, and (ii) one or more spaced discrete members (Figures 1-4).
Regarding claim 11, Chanduszko teaches the waist portion (36, 38) expands in an axis orthogonal to the extension axis in the post-activation state (“waist portion” construed as central portion 38 and whiskers or foam collar 36, [0024], which “expands” orthogonally to the longitudinal axis when released from the deployment catheter).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2010/0131006 (Chanduszko) in view of U.S. Patent Application Publication No. 2007/0282374 (Sogard).
Regarding claim 5, Chanduszko teaches all the limitations of claim 4. Chanduszko teaches the thermal stimuli is an ambient temperature (upon deployment in the body, the device reverts to memory shape, [0021], [0035]), but does not quantify the temperature range.
However, Sogard teaches a three-dimensional (3D) implantable device (abstract; [0022]-[0024]), wherein the device translates from a pre-activation state to a post-activation state in response to a thermal stimuli, wherein the thermal stimuli is an ambient temperature in a range of 35°C to 40°C ([0081]). 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 material of Chanduszko such that the device transforms from the pre-activation state to the post-activation state in response to an ambient temperature in a range of 35°C to 40°C, such as 37°C to 40°C, as taught by Sogard, to that the configuration of the device changes upon placement in the body at its target location following deployment (Sogard: [0081]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2006/0190036 (Wendel): shape memory sealing plug with a plurality of overhangs extending from first and second ends of a waist portion (Figure 3; [0043])
US 2004/0215231 (Fortune): sealing plug with first and second overhands extending from first and second ends of a waist portion (Figures 1-6)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791