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 § 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.
Claim(s) 1-3 and 5-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zenz-Olson et al. US 20150320543 A1, herein referred to as Zenz-Olson.
Regarding claim 1, Zenz-Olson discloses a bioinductive implant (Fig 12J,114; [0085] teaches collagen comprised sheet implant, considered bioinductive) placement device (Fig 1B, 100) comprising: an ergonomic housing (101) containing a plurality of manual actuators (Fig 1a, 105 and 129), each actuator extending external to the housing for actuation by a user (intended use; fully capable see Fig 1a);
a plurality of concentrically and slidably arranged components (Fig 2) extending from the housing to define a surgery application end that is distal to the housing (Fig 2; [0097]), the plurality of concentrically arranged components comprising a main shaft (Fig 12m, 171) nested within a bottom tab assembly (Fig 12j, 115) nested within a tubular sheath (103); and
an application head (104) of a patch-splayer component (Fig 5d) coupled to a distal end of the main shaft and configured to transition between a retracted state (Fig 12h) and an expanded state (Fig 12e) in response to application of, and/or release of, a tensioning force ([0123]);
wherein the plurality of manual actuators are each uniquely associated with one of the patch-splayer component, bottom tab assembly, and tubular sheath ([0154-0155] and [0088]);
wherein sequential actuation of the plurality of manual actuators causes the surgical application end to transition between a loaded state and a deployed state ([0023-0025]; [0154-0155]); and
wherein when in the loaded state the application head of the patch-splayer component is in the retracted state (Fig 12h, sheath and compressed state) and a bioinductive implant patch is folded for insertion into an in vivo surgical site (Fig 12M shows the fold implant), and when in the deployed state the application head of the patch-splayer component is in the expanded state and the bioinductive implant patch is splayed and releasable from the surgery application end onto the in vivo surgical site (Fig 16k; [0155]).
Regarding claim 2, Zenz-Olson discloses wherein the patch-splayer component is comprised of Nitinol ([0101]).
Regarding claim 3, Zenz-Olson discloses wherein the patch-splayer component is comprised of a wire (Fig 8F).
Regarding claim 5, Zenz-Olson discloses wherein the tubular sheath defines a slot (Fig 3, sheath 103 and slits147/159; [0108]).
Regarding claim 6, Zenz-Olson discloses wherein the bottom tab assembly defines a tab (Fig 12j. 115) that extends beneath the bioinductive implant patch when the surgical application end is in the deployed state (Fig 12m).
Regarding claim 7, Zenz-Olson discloses wherein when the application end is in the loaded state, the bioinductive implant patch is folded around the main shaft and the application head of the patch-splayer component is in its retracted state (Fig 12m).
Regarding claim 8, Zenz-Olson discloses wherein when the application end is in the deployed state, the application head of the patch-splayer component is in its expanded state such that it takes a default shape that operates to unfold the bioinductive implant patch from around the main shaft (Fig 16k [0155]).
Regarding claim 9, Zenz-Olson discloses wherein the default shape of the application head of the patch-splayer component approximates one of a circle (Fig 8e), an oval (Fig 8f), and a heart-shape (Fig 8f).
Regarding claim 10, Zenz-Olson discloses wherein the bioinductive implant patch comprises collagen ([0085]).
Regarding claim 11, Zenz-Olson discloses:
a method ([0004]) for using a bioinductive implant placement device according to claim 1, the method comprising:
loading the bioinductive implant device into a loaded state by placing a bioinductive implant patch onto the main shaft ([0016]), applying a tensioning force to the patch-splayer component ([0101]; teaches confined elastic material of splayer), and extending the tubular sheath over the main shaft and application head such that the bioinductive implant patch is folded around the main shaft (Fig 12m);
inserting the bioinductive implant device into an in vivo surgical site (15b); actuating a first manual actuator of the plurality of manual actuators to retract the tubular sheath ([0154]);
actuating a second manual actuator of the plurality of manual actuators to allow the application head of the patch-splayer component to expand to an expanded shape and splay the bioinductive implant patch over the in vivo surgical site ([0097]);
surgically fixing the bioinductive implant patch in place in the in vivo surgical site (Fig 16m; [0151]); actuating a third manual actuator (Fig 4, guidewire410) of the plurality of manual actuators to retract the bottom tab assembly from beneath the bioinductive implant patch (0095);
and retracting the bioinductive implant device from the in vivo surgical site ([0154]).
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.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zenz -Olson in view of Grabinsky et al. US 20230149151 A1, herein referred to as Grabinsky.
Regarding claim 4, Zenz-Olson discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not explicitly disclose wherein the patch-splayer component is comprised of a laser cut tube.
Grabinsky teaches wherein the patch-splayer component is comprised of a laser cut tube (The claimed phrase “a laser cute tube” is being treated as a product-by-process limitation; that is “a tube formed by laser cutting”. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113; Grabinsky teaches laser cut elements [0069]; also see Fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Zenz-Olson to incorporate a laser cut tube, as taught and suggested by Grabinsky in order to allow the tube to be constructed from a single piece of material (Grabinsky [0069]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Park et al. US 20200008920 A1 discloses device for delivering grafts at a surgical site and method
Euteneuer et al. discloses US 20130172997 A1 discloses methods and apparatus for delivering and positioning sheet-like materials in surgery
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/A.F./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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