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 .
Priority
This application claims priority from provisional application 62/905,988 filed 09/25/2019.
Status of Claims
Claims 25-30 are pending.
Claims 1-24 and 31-39 have been cancelled.
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(s) 25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blackburn US 2015/0250576 A1in view of Levy US 2011/0245597 A1 and Euteneuer et al (Euteneuer) US 2010/0191332 A1.
Blackburn discloses the invention substantially as claimed being a rollable sheet (Figures 4-5) implant 10 (Figures 1-9) comprising:
a top layer 12 comprising a biological sheet (Blackburn discloses it as a hernia patch which is considered to be a biological sheet); and
a bottom layer 26 comprising a spring material biased to an open flat configuration ([0028] discloses shape memory alloys), the bottom layer further comprising a rollable frame (the claims do not limit how the frame is rolled, for example upon itself or as a whole device, therefore the frame of Blackburn is fully capable of being rolled in a whole expanded configuration from side to side)
However, Blackburn does not disclose the frame comprises bioabsorbable material or the inner channels/port.
Levy teaches the use of a sheet implant comprising a top layer and a bottom bioabsorbable material [0033] in the same field of endeavor for the purpose of eliminating the removal step and allowing for temporary support while the top layer is absorbed.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bottom layer of Blackburn to include bioabsorbable material as disclosed by Levy in order to eliminate the removal step and allow for temporary support while the top layer is absorbed
Euteneuer teaches the use of a porous plate (Figure 9) comprising a porous top layer 374 in combination with a bottom layer 378 comprising an inflow port 386 for introduction of fluid and inner fluid channels (long open channels in layer 378) including apertures (rectangular ends in layer 378) for disbursement of fluid to the top layer (apertures are in direct communication with the pores 380 of top layer 374) in the same field of endeavor for the purpose of allowing for fluid to be evenly dispersed throughout the implant.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bottom layer of Blackburn to comprise the frame shape of Euteneuer including the inflow port, channels, and apertures in order to better distribute fluid and forces evenly throughout the entire implant.
Furthermore, the channels of Euteneuer disclose an "x" pattern (Figure 9).
In regards to claim 27, the combination of Blackburn, Levy, and Euteneuer as combined above read upon this claim in the same manner, the only difference between this claim and claim 25 is the shape of the channels. However, the channels of Euteneuer include a central strip (narrowed up and down opening of Figure 9) with a plurality of ribs extending perpendicular to the central strip (the middle channels extending left and right at a perpendicular angle to the central strip in Figure 9).
Claim(s) 26, 28, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blackburn, Levy, and Euteneuer (Combination 1) as applied to claims 25 and 27 above, and further in view of Koizumi et al (Koizumi) US 2016/0183990 A1.
Combination 1 discloses the invention substantially as claimed being described above. Claim 26, 28, 29, and 30 only differ from claim 25 above in their description of the shape of the channels.
However, Combination 1 fails to disclose the channels form a honeycomb pattern, a quadrilateral with molded tabs, a round shaped hoop with a plurality of molded tabs disposed on the hoop, or a serpentine shaped spring.
Koizumi discloses a porous sheet implant comprising a bottom layer with channels forming honeycomb pattern (Figure 5), a quadrilateral with molded tabs disposed on the corners of the quadrilateral (Figure 9B includes two quadrilateral shaped diamonds with wider portions at the corners considered to read upon the molded tabs), a round shaped hoop with a plurality of molded tabs disposed on the hoop (Figure 10 includes a plurality of small round hoops surrounding reference numbers 68 with struts extending radially outward which are considered to read upon the molded tabs), and/or a serpentine shaped spring (Koizumi diagonal struts in Figure 9A-B).
It is old and extremely well known to provide channels to dispersion of fluid in a variety of shapes and patterns. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the channels of bottom layer of Blackburn as modified by Euteneuer to have a honeycomb pattern, a quadrilateral pattern with molded tabs, a round shaped hoop with a plurality of molded tabs disposed on the hoop, or a serpentine shaped spring in order to provide uniform distribution of fluid throughout the implant.
In regards to claim 30, Euteneuer further teaches the use of a lower second side of the bottom layer of the frame with a plurality of anchors (Abstract and [0061] teaches the use of barbs hooks and staples for aiding with anchoring to surrounding tissue).
Response to Arguments
Applicant's arguments filed 05/07/2026 have been fully considered but they are not persuasive.
The applicant argues that Blackburn does not disclose a bottom layer comprising spring material because the support member 26 is separate and removable from the sleeve. This is not persuasive because the applicant’s own arguments admit that the support member “may be releasably attached” and that the support member is “selectively removable”. These statements mean that the support member does not have to be removed and is only removed if needed. Therefore Blackburn clearly discloses a hernia patch that includes a bottom layer with a spring material, which it the support member 26.
The applicant argues that the support member is not an integral layer because it is detachable. This argument is moot because there is no recitation in the claims for the term integral. Furthermore an integral portion may still be removable, it just depends on the type of connection. Wallpaper on a wall would be integral to the wall, but with heat, chemicals, or physical scraping it can still be removed from the wall, leaving the wall intact.
The applicant then argues that the support member is contained in the sleeve and removed so it is a distinct component and not a layer of the body. This is not persuasive because it is arguing well beyond the scope of the claims. The claims broadly require the bottom layer “comprising a spring material”. The support member contained within the sleeve clearly qualifies as a bottom layer comprising the spring material because the bottom layer of Blackburn includes a sleeve containing the support member, which is formed from nitinol which is a spring metal.
The applicant goes on to argue that Blackburn does not disclose a layered frame within a bottom layer. Again, the bottom layer of the prior art combination includes the sleeve and support frame, which anticipates the current claim language. A layer can include a variety of components and still be considered a single layer.
The applicant then argues that Blackburn teaches away from providing the support member. This argument fails on its face because Blackburn, as admitted by the applicant, teaches that the support member “may be releasably attached” and that the support member is “selectively removable”. There can be no teaching away if the reference clearly teaches that the act is optional. The applicant’s citations of configurations where it is removed are moot because they are all describing optional actions and configurations. Furthermore, even if it was removed at a later time, the claims are directed at the initial product. The claims do not describe a method for using the product or a configuration after a particular time of implantation.
Finally, the applicant argues that there is no motivation to combine the fluid channels to Blackburn. This is not persuasive because Blackburn discloses the desire for ingrowth into his implant. As stated above, Euteneuer teaches the use of a porous plate with a bottom layer comprising an inflow port for introduction of fluid and inner fluid channels including apertures for disbursement of fluid to the top layer. These channels and pores will help ensure uniform distribution of all fluids and materials. The fluids could include medicine and body fluids/cells which promote uniform and full ingrowth.
In order to advance prosecution they are advised to better define the spring structure to be narrowed in a manner more consistent with their arguments.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/ Primary Examiner, Art Unit 3774
Prosecution Insights