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 .
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.
Claims 1, 3, 7-10, and 21-25 are 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. 2009/0227938 (Fasching et al.).
Regarding claim 1, Chanduszko teaches a 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 an extension axis, between a first waist end and a second waist end (Figures 3-4);
one or more first overhangs (32a-32c) coupled to or proximal the first waist end (Figures 3-4); and
one or more second overhangs (34a-34c) coupled to or proximal the second waist end (Figures 3-4),
wherein the hernia plug is formed of a thermo-responsive smart memory material and is configured to transform between a pre-activation shape and a post-activation shape in response to a thermal stimuli (shape memory: “a closure device is made from a single polymer tube 10 by providing slits 12, 14 at both ends and setting a desired shape, such as by thermo-mechanical treatment, to produce a design as shown in FIG. 2. This treatment can include heating or other thermal steps, and mechanical steps, such as folding back the struts”, [0008], [0018]-[0019]; “pre-activation state” shown in Figure 1 and “post-activation state” shown in Figures 2-4; [0024]; Figures 3-4).
Chanduszko does not teach the waist portion is expandable in an axis orthogonal to the extension axis in the post-activated state relative to the pre-activation shape.
However, Fasching teaches a hernia plug (30) (abstract; The limitation “hernia plug” is intended use. Since the plug of Fasching is configured and employed for closing an aperture in body tissue, the plug is capable of performing the claimed intended use, abstract, [0011], Figures 6A-6H), comprising a waist portion extending along an extension axis, between a first waist end and a second waist end ([0056]; See annotated Figure 6F below); a first overhang coupled to the first waist end (Figures 6F-6H); and a second overhang coupled to the second waist end (Figures 6F-6H); wherein the plug is formed of a thermo-responsive smart memory material and is configured to transform between a pre-activation shape and a post-activation shape in response to a thermal stimulus, the waist portion expandable in an axis orthogonal to the extension axis in the pos-activation state relative to the pre-activation state (“The wound closure device can be a biocompatible material. The biocompatible material can be selected from at least one of a compressible material, temperature dependent material, shape memory material, a swellable material, and an expandable material.”, emphasis added,, [0045]; [0056]; see Figures 6E-6H).
PNG
media_image1.png
266
206
media_image1.png
Greyscale
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 waist portion of Chanduszko such that, in response to a thermal stimulus, the waist portion is expandable in an axis orthogonal to the extension axis in its post-activation shape relative to its pre-activation shape as taught by Fasching, in order to fully close the aperture in the body tissue and retain its position in the aperture.
Regarding claim 3, 7, and 8, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified teaches 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 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 in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified teaches the hernia plug (30) is deployable at a hernia-defect site in the post-activation shape, and the one or more first overhangs are configured to engage a groin-side of an abdominal wall at the hernia-defect site, and the one or more second overhangs are configured to engage an abdomen-side of the abdominal wall (The limitations “deployable at a hernia-defect site in the post-activated state”, “to engage a groin-side of an abdominal wall at the hernia-defect site”, and “to engage an abdomen-side of the abdominal wall” are 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 functions. See “anchoring”, [0007], [0018], [0024]-[0025], and Figures 1-5).
Regarding claim 10, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified 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 21, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified teaches the one or more first and second overhangs (32a-32c, 34a-34c) comprise two or more first and second overhangs, respectively ([0024]; Figures 3-4).
Regarding claim 22, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified teaches the first and second overhangs (32a-32c, 34a-34c) are translated outwardly, away from the waist portion, in the post-activation shape relative to the pre-activation shape (Figures 2-3).
Regarding claim 23, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified teaches the waist portion comprises a hollow interior (tube, [0018]-[0019]; Figures 2-4).
Regarding claim 24, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified teaches the waist portion includes a plurality of perforations (“perforations” or openings shown in whiskers 36, [0024]; Figure 3).
Regarding claim 25, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified teaches the waist portion comprises a plurality of discrete elongated members (36) extending along the extension axis ([0024]; Figure 3).
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. 2009/0227938 (Fasching et al.) as applied to claim 1, and further in view of U.S. Patent Application Publication No. 2007/0282374 (Sogard).
Regarding claim 5, Chanduszko in view of Fasching teaches all the limitations of claim 1. Chanduszko as modified 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 as modified 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]).
Response to Arguments
Applicant’s arguments, see page 5, filed 11 May 2026, with respect to the informality objections of claims 3, 4, and 8 have been fully considered and are persuasive in light of the amendments to the claims. The objections of 15 January 2026 has been withdrawn.
Applicant’s arguments, see pages 5-7, filed 11 May 2026, with respect to the rejections of claim 1 and its dependents under 35 U.S.C. 102 and 103 have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejections have been withdrawn. However, upon further consideration and as necessitated by the amendments to the claims, a new ground(s) of rejection is made in view of Chanduszko and Farsching as these references in combination better teach and/or suggest applicant’s claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
FR 2641692 (Kamiya et al., see attached machine translation): wound plug formed of shape memory material for expanding to fill the wound (Figures 4-5)
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
Prosecution Insights