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 Objections
Claims 10 and 17- 20 are objected to because of the following informalities:
Claim 10, Line 3 states “implant to tissue”, it is suggested to change this to “implant to a tissue”.
Claim 17, Line 1 states “claim 16 further”, it is suggested to change this to “claim 16, further”.
Claims 18- 20 are objected to for being dependent on or from claim 17.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17- 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the claim limitation “further including a movable implant supporting flange member, the implant holding portion being configured to receive the sheet- like implant between the movable implant supporting flange member and the fixed implant supporting flange member”. It is unclear as to if applicant intends to have the implant holding portion comprise the fixed implant supporting flange member and the movable implant, which is not established within claim 17 or within claim 16 of which claim 17 depends, or how the implant holding portion is configured to receive the sheet-like implant between the movable implant supporting flange member and the fixed implant supporting flange member if these members are not a part of the implant holding portion. For purposes of examination, this limitation is herein interpreted as the implant holding portion comprising the fixed implant supporting flange member and the movable implant supporting flange member.
Claims 18- 20 are rejected for being dependent on or from rejected claim 17.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-7, 9, 16- 17, and 19- 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zenz- Olson (US 10,258,459).
Regarding claim 1, Zenz- Olson teaches an implant delivery device (100)(Figs. 1A- 7 and Fig. 8B)(abstract), comprising:
A handle (107) disposed at a proximal end of the implant delivery device (see annotated Fig. 1A below) and configured to be grasped by a user (Column 3, Lines 11- 25);
An outer shaft (outer tube 102, connector 104, inner tube 110, head 113) extending from the handle to a distal end of the implant delivery device (see annotated Fig. 1A below); and
An implant holding portion (sheath 103, implant positioning component 115) proximate the distal end of the implant delivery device (see annotated Fig. 1A below), the implant holding portion being configured to retain a sheet- like implant (implant 114)(Column 7, Lines 33- 49) during implantation of the sheet-like implant (Column 10, Lines 44- 58), wherein the implant holding portion is configured to receive the sheet-like implant between a fixed implant supporting flange member (implant positioning component 115)(Fig. 8F)(Column 15, Lines 46- 49) and a movable implant supporting flange member (sheath 103)(As sheath 103 is taught to move and supports the implant (Column 10, Lines 28- 43), it is considered a movable implant supporting flange member.), the fixed implant supporting flange member associated with the outer shaft (see annotated Fig. 1A below) and configured to support the sheet-like implant on a first side of the sheet-like implant, wherein the fixed implant supporting flange member includes a pair of substantially triangular-shaped wings extending from a centerline axis of the outer shaft (see annotated Fig. 8B below)(Column 10, Lines 47- 52 and Column 11, Lines 42- 45).
PNG
media_image1.png
581
1073
media_image1.png
Greyscale
PNG
media_image2.png
600
479
media_image2.png
Greyscale
Regarding claim 2, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the pair of substantially triangular- shaped wings include a first wing and a second wing, the fixed implant supporting flange member having a maximum width extending from a first tip of the first wing to a second tip of the second wing (see annotated Fig. 8B below).
PNG
media_image3.png
600
479
media_image3.png
Greyscale
Regarding claim 3, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the fixed implant supporting flange member further includes a necked- down portion at a distal end thereof, wherein the necked down portion has a width that is narrower than the maximum width extending from the first tip of the first wing to the second tip of the second wing (see annotated Fig. 8B below).
PNG
media_image4.png
564
477
media_image4.png
Greyscale
Regarding claim 5, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the first tip of the first wing and the second tip of the second wing are substantially curved (see annotated Fig. 8B below).
PNG
media_image5.png
371
470
media_image5.png
Greyscale
Regarding claim 6, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the first tip of the first wing and the second tip of the second wing are substantially elongated, forming elongated edges extending in a longitudinal direction in substantial alignment with the centerline axis (see annotated Fig. 8B below).
PNG
media_image6.png
557
470
media_image6.png
Greyscale
Regarding claim 7, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the fixed implant supporting flange member includes one window in each wing of the pair of substantially triangular- shaped wings (see annotated Fig. 8B below).
PNG
media_image7.png
546
470
media_image7.png
Greyscale
Regarding claim 9, Zenz- Olson teaches the implant delivery device as discussed above.
Regarding wherein each wing of the pair of substantially triangular- shaped wings has one edge that is concave, as Zenz- Olson teaches in Column 17, Lines 28- 32 that the implant positioned component can curve out of a plane, therefore when looking at the side of the fixed implant supporting flange member, the edge would be concave for each wing.
Regarding claim 16, Zenz- Olson teaches an implant delivery device (100)(Figs. 1A- 7 and Fig. 8B)(abstract), comprising:
An implant holding portion (sheath 103, implant positioning component 115) proximate a distal end of the implant delivery device (see annotated Fig. 1A below), the implant holding portion being configured to retain a sheet- like implant (implant 114)(Column 7, Lines 33- 49) during implantation of the sheet-like implant (Column 10, Lines 44- 58); and
A fixed implant supporting flange member (implant positioning component 115)(Fig. 8F)(Column 15, Lines 46- 49) associated with an outer shaft (outer tube 102, connector 104, inner tube 110, head 113) of the implant delivery device (see annotated Fig. 1A below), wherein the fixed implant supporting flange member includes a pair of substantially triangular-shaped wings extending from a centerline axis of the outer shaft (see annotated Fig. 8B below).
PNG
media_image1.png
581
1073
media_image1.png
Greyscale
PNG
media_image2.png
600
479
media_image2.png
Greyscale
Regarding claim 17, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson further teaches the device further including a movable implant supporting flange member (sheath 103)(As sheath 103 is taught to move and supports the implant (Column 10, Lines 28- 43), it is considered a movable implant supporting flange member.), the implant holding portion being configured to receive the sheet-like implant between the movable implant supporting flange member and the fixed implant supporting flange member (Column 10, Lines 47- 52 and Column 11, Lines 42- 45).
Regarding claim 19, Zenz- Olson teaches the implant delivery device as discussed above.
Regarding wherein the sheet-like implant (114) is retained in a recess by the movable implant supporting flange member (sheath 103) and the fixed implant supporting flange member (115), since Zenz- Olson teaches that the movable implant supporting flange member covers the fixed implant supporting flange member and the implant (Column 10, Lines 25- 43), then the area between the movable implant supporting flange member and the fixed implant supporting flange member when the movable implant supporting flange member is covering both features would be a recess that retains the implant.
Regarding claim 20, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz-Olson further teaches wherein the movable implant supporting flange member (sheath 103) is configured to be movable between a first position in which the movable implant supporting flange member holds the sheet-like implant within the recess (Column 10, Lines 28- 33) and a second position in which the sheet-like implant is unencumbered by the movable implant supporting flange member, thus enabling release of the sheet-like implant from the implant holding portion of the implant delivery device (Column 10, Lines 38- 43).
Alternate Interpretation of Zenz- Olson, regarding the movable implant supporting flange member.
Claim(s) 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zenz- Olson (US 10,258,459).
Regarding claim 16, Zenz- Olson teaches an implant delivery device (100)(Figs. 1A- 7 and Fig. 8B)(abstract), comprising:
An implant holding portion (lower beam 151, implant positioning component 115) proximate a distal end of the implant delivery device (see annotated Fig. 1A below), the implant holding portion being configured to retain a sheet- like implant (implant 114)(Column 7, Lines 33- 49) during implantation of the sheet-like implant (Column 10, Lines 44- 58); and
A fixed implant supporting flange member (implant positioning component 115)(Fig. 8F)(Column 15, Lines 46- 49) associated with an outer shaft (outer tube 102, connector 104, inner tube 110, head 113) of the implant delivery device (see annotated Fig. 1A below), wherein the fixed implant supporting flange member includes a pair of substantially triangular-shaped wings extending from a centerline axis of the outer shaft (see annotated Fig. 8B below).
PNG
media_image8.png
581
1073
media_image8.png
Greyscale
PNG
media_image2.png
600
479
media_image2.png
Greyscale
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zenz- Olson (US 10,258,459).
Regarding claim 4, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson does not teach in the current embodiment wherein at least the first wing includes a proximal edge that extends at a first angle with respect to the centerline axis and a distal edge that extends at a second angle with respect to the centerline axis, the second angle being larger than the first angle.
Zenz- Olson teaches in a second embodiment a fixed implant supporting flange member (implant positioning component 115) including a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft, wherein at least the first wing includes a proximal edge that extends at a first angle with respect to the centerline axis and a distal edge that extends at a second angle with respect to the centerline axis, the second angle being larger than the first angle (see annotated Fig. 8F below)(Column 16, Lines 37- 44 and Column 17, Lines 32- 35).
PNG
media_image9.png
510
506
media_image9.png
Greyscale
It would have been obvious to one of ordinary skill in the art to modify the shape of the pair of substantially triangular- shaped wings as taught by the first embodiment of Zenz- Olson to have the shape as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding claim 8, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz-Olson does not teach in the current embodiment wherein the fixed implant supporting flange member is asymmetrical in the proximal- distal direction.
Zenz- Olson teaches in a second embodiment a fixed implant supporting flange member (implant positioning component 115) including a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft, wherein the fixed implant supporting flange member is asymmetrical in the proximal- distal direction (see annotated Fig. 8F below)( Column 16, Lines 37- 44 and Column 17, Lines 32- 35).
PNG
media_image10.png
422
499
media_image10.png
Greyscale
It would have been obvious to one of ordinary skill in the art to modify the shape of the pair of substantially triangular- shaped wings as taught by the first embodiment of Zenz- Olson to have the shape as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding claim 10, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson does not teach in the current embodiment wherein each wing of the pair of substantially triangular- shaped wings includes openings through which anchors may be inserted into the sheet-like implant to secure the sheet-like implant to a tissue of a patient.
However, Zenz- Olson teaches in a different embodiment wherein the fixed implant supporting flange member (115) comprises wings, wherein each wing includes openings (Column 16, Lines 41- 44).
It would have been obvious to modify each wing of the pair of wings as taught by the first embodiment of Zenz- Olson to include openings as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding that the openings allows anchors to be inserted into the sheet-like implant to secure the sheet-like implant to a tissue of a patient, it would be obvious to one of ordinary skill in the art that the openings are capable of accepting anchors, and as the fixed implant supporting flange member overlays the implant (Column 11, Lines 41- 52), then when an anchor is inserted into the opening, the anchor would contact the sheet-like implant and be able to secure it to a tissue of a patient.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zenz- Olson (US 10,258,459) in view of Winterbottom et al. (US 2003/0083747).
Regarding claim 13, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson does not teach wherein the fixed implant supporting flange member includes one or more holes for receiving a rivet of a rivet strip to secure the fixed implant supporting flange member to the outer shaft of the implant delivery device.
Winterbottom (Winterbottom et al.) teaches a similar device (140)(abstract)(Fig. 17) with a securing point featuring a rivet (163) of a rivet strip and a hole (see annotated Fig. 17 below) which secures one part of the device to another (Paragraph 0164).
PNG
media_image11.png
667
1162
media_image11.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art to modify the connection between the fixed implant supporting flange member and the outer shaft to be a rivet and hole connection as taught by Winterbottom for the purpose of connecting two pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one connection type for another because both connections are disclosed as equivalent structures for connecting pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164) and substitution of one for the other would have resulted in the predictable result of providing a way of connection between two parts of a device. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the fixed implant supporting member including one or more holes for receiving a rivet of a rivet strip to secure the fixed implant supporting flange member to the outer shaft of the implant delivery device, for Zenz- Olson, the equivalent of the rivet would be the T-shaped extension on the fixed implant supporting flange member, while the holes would be the T-shaped depression within the outer shaft (Column 11, Lines 46-52). However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination through reversing the holes and the rivet to have the fixed implant supporting member contain the one or more holes and the outer shaft comprises a rivet of a rivet strip, since it has been held that mere reversal of parts is an obvious modification of the prior art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). See MPEP 2144.04(VI)(A).
Regarding claim 14, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the fixed implant supporting flange includes one or more cylindrical projects forming a rivet configured to secure the fixed implant supporting flange member to the outer shaft of the implant delivery device.
Winterbottom (Winterbottom et al.) teaches a similar device (140)(abstract)(Fig. 17) with a securing point featuring a cylindrical rivet (163) of a rivet strip and a hole (see annotated Fig. 17 below) which secures one part of the device to another (Paragraph 0164).
PNG
media_image11.png
667
1162
media_image11.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art to modify the connection between the fixed implant supporting flange member and the outer shaft to be a rivet and hole connection as taught by Winterbottom for the purpose of connecting two pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one connection type for another because both connections are disclosed as equivalent structures for connecting pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164) and substitution of one for the other would have resulted in the predictable result of providing a way of connection between two parts of a device. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the fixed implant supporting member including includes one or more cylindrical projects forming a rivet, for Zenz- Olson, the equivalent of the rivet would be the T-shaped extension on the fixed implant supporting flange member (Column 11, Lines 46-52) and therefore the fixed implant supporting member would include one or more cylindrical projects forming a rivet.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zenz- Olson (US 10,258,459) in view of Mackool (US 2005/0234395).
Regarding claim 18, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson teaches wherein the fixed implant supporting flange member (115) is flexible and resilient such that the fixed implant supporting flange member may be at least partially collapsed upon delivery through a cannula (In Column 12, Lines 58- 67, Zenz- Olson teaches that the fixed implant supporting flange member is capable of collapsing when inserted within the sheath, therefore it is partially collapsed upon delivery through a cannula.).
Zenz- Olson does not teach wherein the movable implant supporting flange member is flexible and resilient such that the movable implant supporting flange member may be at least partially collapsed upon delivery through a cannula.
Mackool teaches a similar device (Fig. 1)(abstract) for delivering a treatment to a tissue (Paragraph 0002), the device comprising a flexible outer sheath (32) that is capable of collapsing and expanding and being slid over other parts of the device (Paragraph 0015).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the movable implant supporting flange member to be the flexible and resilient outer sheath as taught by Mackool for the purpose of acting as an outer sheath during the insertion of a device into the body (Zenz- Olson, Column 10, Lines 25- 43; Mackool, Paragraph 0015). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one outer sheath for another because both are disclosed as equivalent structures for covering another part of the device (Zenz- Olson, Column 10, Lines 25- 43; Mackool, Paragraph 0015) and substitution of one for the other would have resulted in the predictable result of protecting the covered part of the device during insertion. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the movable implant supporting flange member being flexible and resilient such that the movable implant supporting flange member may be at least partially collapsed upon delivery through a cannula, if the device is inserted into a cannula that has a smaller diameter than the movable implant supporting flange member, then it would partially collapse upon being delivered into the cannula.
In the alternative interpretation of Zenz- Olson, regarding the movable implant supporting flange member.
Claim(s) 1- 12, 15, 17, and 19- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zenz- Olson (US 10,258,459) in view of Zannis et al. (US 2004/0267304).
Regarding claim 1, Zenz- Olson teaches an implant delivery device (100)(Figs. 1A- 7 and Fig. 8B)(abstract), comprising:
A handle (107) disposed at a proximal end of the implant delivery device (see annotated Fig. 1A below) and configured to be grasped by a user (Column 3, Lines 11- 25);
An outer shaft (outer tube 102, connector 104, inner tube 110, head 113) extending from the handle to a distal end of the implant delivery device (see annotated Fig. 1A below); and
An implant holding portion (lower beam 151, implant positioning component 115) proximate the distal end of the implant delivery device (see annotated Fig. 1A below), the implant holding portion being configured to retain a sheet- like implant (implant 114)(Column 7, Lines 33- 49) during implantation of the sheet-like implant (Column 10, Lines 44- 58), wherein the implant holding portion is configured to receive the sheet-like implant between a fixed implant supporting flange member (implant positioning component 115)(Fig. 8F)(Column 15, Lines 46- 49) and an implant supporting flange member (lower beam 151), the fixed implant supporting flange member associated with the outer shaft (see annotated Fig. 1A below) and configured to support the sheet-like implant on a first side of the sheet-like implant, wherein the fixed implant supporting flange member includes a pair of substantially triangular-shaped wings extending from a centerline axis of the outer shaft (see annotated Fig. 8B below)(Column 10, Lines 47- 52 and Column 11, Lines 42- 45).
PNG
media_image8.png
581
1073
media_image8.png
Greyscale
PNG
media_image2.png
600
479
media_image2.png
Greyscale
Zenz- Olson does not teach a movable implant supporting flange member.
Zannis (Zannis et al.) teaches a similar an implant delivery device (210)(Figs. 24- 32)(abstract), comprising: a handle (212) disposed at a proximal end of the implant delivery device (see annotated Fig. 24 below) and configured to be grasped by a user (Paragraph 0089); an outer shaft (216) extending from the handle to a distal end of the implant delivery device (see annotated Fig. 24 below)(Paragraph 0088); and an implant holding portion (slide arm 218, distal end 282 and well 283) proximate the distal end of the implant delivery device (see annotated Fig. 24 below), the implant holding portion being configured to retain an implant (294) during implantation of the implant (Paragraph 0095), wherein the implant holding portion is configured to receive the sheet-like implant between a fixed implant supporting flange member (distal end 282 and well 283) and an implant supporting flange member (slide arm 218), the fixed implant supporting flange member associated with the outer shaft (see annotated Fig. 24 below) and configured to support the sheet-like implant on a first side of the sheet-like implant (Paragraph 0095).
PNG
media_image12.png
883
828
media_image12.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant supporting flange member to be movable as taught by Zannis, since Zenz- Olson teaches that the lower beam and upper beam can have an active retention mechanism (Zenz- Olson, Column 11, Lines 36- 40), and Zannis teaches an active retention mechanism (Zannis, Paragraph 0095). Therefore the lower beam can be modified to be movable relative to the upper beam.
Regarding claim 2, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the pair of substantially triangular- shaped wings include a first wing and a second wing, the fixed implant supporting flange member having a maximum width extending from a first tip of the first wing to a second tip of the second wing (see annotated Fig. 8B below).
PNG
media_image3.png
600
479
media_image3.png
Greyscale
Regarding claim 3, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the fixed implant supporting flange member further includes a necked- down portion at a distal end thereof, wherein the necked down portion has a width that is narrower than the maximum width extending from the first tip of the first wing to the second tip of the second wing (see annotated Fig. 8B below).
PNG
media_image4.png
564
477
media_image4.png
Greyscale
Regarding claim 4, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson does not teach in the current embodiment wherein at least the first wing includes a proximal edge that extends at a first angle with respect to the centerline axis and a distal edge that extends at a second angle with respect to the centerline axis, the second angle being larger than the first angle.
Zenz- Olson teaches in a second embodiment a fixed implant supporting flange member (implant positioning component 115) including a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft, wherein at least the first wing includes a proximal edge that extends at a first angle with respect to the centerline axis and a distal edge that extends at a second angle with respect to the centerline axis, the second angle being larger than the first angle (see annotated Fig. 8F below)(Column 16, Lines 37- 44 and Column 17, Lines 32- 35).
PNG
media_image9.png
510
506
media_image9.png
Greyscale
It would have been obvious to one of ordinary skill in the art to modify the shape of the pair of substantially triangular- shaped wings as taught by the first embodiment of Zenz- Olson to have the shape as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding claim 5, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the first tip of the first wing and the second tip of the second wing are substantially curved (see annotated Fig. 8B below).
PNG
media_image5.png
371
470
media_image5.png
Greyscale
Regarding claim 6, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the first tip of the first wing and the second tip of the second wing are substantially elongated, forming elongated edges extending in a longitudinal direction in substantial alignment with the centerline axis (see annotated Fig. 8B below).
PNG
media_image6.png
557
470
media_image6.png
Greyscale
Regarding claim 7, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson further teaches wherein the fixed implant supporting flange member includes one window in each wing of the pair of substantially triangular- shaped wings (see annotated Fig. 8B below).
PNG
media_image7.png
546
470
media_image7.png
Greyscale
Regarding claim 8, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz-Olson does not teach in the current embodiment wherein the fixed implant supporting flange member is asymmetrical in the proximal- distal direction.
Zenz-Olson does not teach in the current embodiment wherein the fixed implant supporting flange member is asymmetrical in the proximal- distal direction.
Zenz- Olson teaches in a second embodiment a fixed implant supporting flange member (implant positioning component 115) including a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft, wherein the fixed implant supporting flange member is asymmetrical in the proximal- distal direction (see annotated Fig. 8F below)( Column 16, Lines 37- 44 and Column 17, Lines 32- 35).
PNG
media_image10.png
422
499
media_image10.png
Greyscale
It would have been obvious to one of ordinary skill in the art to modify the shape of the pair of substantially triangular- shaped wings as taught by the first embodiment of Zenz- Olson to have the shape as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding claim 9, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Regarding wherein each wing of the pair of substantially triangular- shaped wings has one edge that is concave, as Zenz- Olson teaches in Column 17, Lines 28- 32 that the implant positioned component can curve out of a plane, therefore when looking at the side of the fixed implant supporting flange member, the edge would be concave for each wing.
Regarding claim 10, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson does not teach in the current embodiment wherein each wing of the pair of substantially triangular- shaped wings includes openings through which anchors may be inserted into the sheet-like implant to secure the sheet-like implant to a tissue of a patient.
However, Zenz- Olson teaches in a different embodiment wherein the fixed implant supporting flange member (115) comprises wings, wherein each wing includes openings (Column 16, Lines 41- 44).
It would have been obvious to modify each wing of the pair of wings as taught by the first embodiment of Zenz- Olson to include openings as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding that the openings allows anchors to be inserted into the sheet-like implant to secure the sheet-like implant to a tissue of a patient, it would be obvious to one of ordinary skill in the art that the openings are capable of accepting anchors, and as the fixed implant supporting flange member overlays the implant (Column 11, Lines 41- 52), then when an anchor is inserted into the opening, the anchor would contact the sheet-like implant and be able to secure it to a tissue of a patient.
Regarding claim 11, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz- Olson teaches wherein the movable implant supporting flange member (lower beam 151) has a surface area that falls completely within the surface area of the fixed implant supporting flange member (115)(see annotated Fig. 5D below)(As the embodiment of the fixed implant supporting flange member is the one shown in Fig. 8B which has a greater surface area than the 115 depicted in Fig. 5D, the lower beam’s surface area would be within the surface area of the fixed implant supporting flange member.).
Regarding claim 12, Zenz- Olson teaches the implant delivery device as discussed above.
Regarding wherein the movable implant supporting flange member has a shape that is substantially similar to that of the fixed implant supporting flange member, since, as discussed above, the movable implant supporting flange member has a surface area that falls completely within the surface area of the fixed implant supporting flange member, then it would have a shape that is substantially similar to the fixed implant supporting flange member.
Regarding claim 15, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant supporting flange member to be movable as taught by Zannis, since Zenz- Olson teaches that the lower beam and upper beam can have an active retention mechanism (Zenz- Olson, Column 11, Lines 36- 40), and Zannis teaches an active retention mechanism (Zannis, Paragraph 0095). Therefore the lower beam can be modified to be movable relative to the upper beam.
Regarding wherein the movable implant supporting flange member is configured to be slidable between a first, distal position and a second, proximal position, Zannis teaches that the movable implant support flange member (Zannis, slide arm 218; in the combination, lower beam 151) is slidable between a first, distal position to a second proximal position (Paragraphs 0094- 0095).
Regarding wherein, in the first, distal position, the movable implant supporting flange member secures the implant against the fixed implant supporting flange member, thus holding the implant in an unfurled configuration, Zannis teaches that the movable implant support flange member (Zannis, slide arm 218; in the combination, lower beam 151) has a first, distal position which secures the implant against the fixed implant supporting flange member (see Fig. 32)(Paragraph 0095).
Regarding wherein, in the second, proximal position, the movable implant supporting flange member is withdrawn from the distal end of the implant delivery device, thus enabling release of the sheet-like implant, Zannis teaches that the movable implant support flange member (Zannis, slide arm 218; in the combination, lower beam 151) has a second, proximal position wherein the movable implant supporting flange member is withdrawn from the distal end of the implant delivery device (see Fig. 31)(Paragraph 0095).
Regarding claim 17, Zenz- Olson teaches the implant delivery device as discussed above.
Zenz- Olson teaches an implant supporting flange member (lower beam 151), the implant holding portion being configured to receive the implant between the implant supporting flange member and the fixed implant supporting flange member (Column 7, Lines 33- 49, Column 10, Lines 44- 58).
Zenz- Olson does not teach the device further including a movable implant supporting flange member.
Zannis (Zannis et al.) teaches a similar an implant delivery device (210)(Figs. 24- 32)(abstract), comprising: a handle (212) disposed at a proximal end of the implant delivery device (see annotated Fig. 24 below) and configured to be grasped by a user (Paragraph 0089); an outer shaft (216) extending from the handle to a distal end of the implant delivery device (see annotated Fig. 24 below)(Paragraph 0088); and an implant holding portion (slide arm 218, distal end 282 and well 283) proximate the distal end of the implant delivery device (see annotated Fig. 24 below), the implant holding portion being configured to retain an implant (294) during implantation of the implant (Paragraph 0095), wherein the implant holding portion is configured to receive the sheet-like implant between a fixed implant supporting flange member (distal end 282 and well 283) and an implant supporting flange member (slide arm 218), the fixed implant supporting flange member associated with the outer shaft (see annotated Fig. 24 below) and configured to support the sheet-like implant on a first side of the sheet-like implant (Paragraph 0095).
PNG
media_image12.png
883
828
media_image12.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant supporting flange member to be movable as taught by Zannis, since Zenz- Olson teaches that the lower beam and upper beam can have an active retention mechanism (Zenz- Olson, Column 11, Lines 36- 40), and Zannis teaches an active retention mechanism (Zannis, Paragraph 0095). Therefore the lower beam can be modified to be movable relative to the upper beam.
Regarding claim 19, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
The combination further teaches wherein the sheet-like implant (114) is retained in a recess by the movable implant supporting flange member (lower beam 151) and the fixed implant supporting flange member (115)(Column 11, Lines 40- 52).
Regarding claim 20, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
Zenz-Olson further teaches wherein the movable implant supporting flange member is configured to be movable between a first position in which the movable implant supporting flange member holds the sheet-like implant within the recess and a second position in which the sheet-like implant is unencumbered by the movable implant supporting flange member, thus enabling release of the sheet-like implant from the implant holding portion of the implant delivery device.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant supporting flange member to be movable as taught by Zannis, since Zenz- Olson teaches that the lower beam and upper beam can have an active retention mechanism (Zenz- Olson, Column 11, Lines 36- 40), and Zannis teaches an active retention mechanism (Zannis, Paragraph 0095). Therefore the lower beam can be modified to be movable relative to the upper beam.
Regarding wherein the movable implant supporting flange member is configured to be movable between a first position and a second position, Zannis teaches that the movable implant support flange member (Zannis, slide arm 218; in the combination, lower beam 151) is slidable between a first position to a second position (Zannis, Paragraphs 0094- 0095).
Regarding wherein, in the first position, the movable implant supporting flange member holds the implant within the recess, Zannis teaches that the movable implant support flange member (Zannis, slide arm 218; in the combination, lower beam 151) has a first position which holds the implant within the recess (Zannis, see Fig. 32, Paragraph 0095), and Zenz- Olsen teaches that the implant is within the recess in the first position (Zenz- Olsen, Column 11, Lines 36- 52).
Regarding wherein, in the second position, in which the sheet-like implant is unencumbered by the movable implant supporting flange member, thus enabling release of the sheet-like implant from the implant holding portion of the implant delivery device, Zannis teaches that the movable implant support flange member (Zannis, slide arm 218; in the combination, lower beam 151) has a second position wherein the movable implant supporting flange member is withdrawn from the distal end of the implant delivery device making the implant be unencumbered (Zannis, see Fig. 31 and Paragraph 0095).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zenz- Olson (US 10,258,459) in view of Zannis et al. (US 2004/0267304), as applied to claim 1 above, in further view of Winterbottom et al. (US 2003/0083747).
Regarding claim 13, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
The combination does not teach wherein the fixed implant supporting flange member includes one or more holes for receiving a rivet of a rivet strip to secure the fixed implant supporting flange member to the outer shaft of the implant delivery device.
Winterbottom (Winterbottom et al.) teaches a similar device (140)(abstract)(Fig. 17) with a securing point featuring a rivet (163) of a rivet strip and a hole (see annotated Fig. 17 below) which secures one part of the device to another (Paragraph 0164).
PNG
media_image11.png
667
1162
media_image11.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art to modify the connection between the fixed implant supporting flange member and the outer shaft to be a rivet and hole connection as taught by Winterbottom for the purpose of connecting two pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one connection type for another because both connections are disclosed as equivalent structures for connecting pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164) and substitution of one for the other would have resulted in the predictable result of providing a way of connection between two parts of a device. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the fixed implant supporting member including one or more holes for receiving a rivet of a rivet strip to secure the fixed implant supporting flange member to the outer shaft of the implant delivery device, for Zenz- Olson, the equivalent of the rivet would be the T-shaped extension on the fixed implant supporting flange member, while the holes would be the T-shaped depression within the outer shaft (Column 11, Lines 46-52). However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination through reversing the holes and the rivet to have the fixed implant supporting member contain the one or more holes and the outer shaft comprises a rivet of a rivet strip, since it has been held that mere reversal of parts is an obvious modification of the prior art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). See MPEP 2144.04(VI)(A).
Regarding claim 14, Zenz- Olson and Zannis make obvious the implant delivery device as discussed above.
The combination does not teach wherein the fixed implant supporting flange includes one or more cylindrical projects forming a rivet configured to secure the fixed implant supporting flange member to the outer shaft of the implant delivery device.
Winterbottom (Winterbottom et al.) teaches a similar device (140)(abstract)(Fig. 17) with a securing point featuring a cylindrical rivet (163) of a rivet strip and a hole (see annotated Fig. 17 below) which secures one part of the device to another (Paragraph 0164).
PNG
media_image11.png
667
1162
media_image11.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art to modify the connection between the fixed implant supporting flange member and the outer shaft to be a rivet and hole connection as taught by Winterbottom for the purpose of connecting two pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one connection type for another because both connections are disclosed as equivalent structures for connecting pieces of a device together (Zenz- Olson, Column 11, Lines 46- 52; Winterbottom, Paragraph 0164) and substitution of one for the other would have resulted in the predictable result of providing a way of connection between two parts of a device. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the fixed implant supporting member including includes one or more cylindrical projects forming a rivet, for Zenz- Olson, the equivalent of the rivet would be the T-shaped extension on the fixed implant supporting flange member (Column 11, Lines 46-52) and therefore the fixed implant supporting member would include one or more cylindrical projects forming a rivet.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 15- 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 9 of U.S. Patent No. 11,259,939 (‘939) in view of Zenz- Olson (US 10,258,459).
Regarding claim 1, ‘939 claims an implant delivery device, comprising: a handle disposed at a proximal end of the implant delivery device and configured to be grasped by a user; an outer shaft extending from the handle to a distal end of the implant delivery device; and an implant holding portion proximal the distal end of the implant delivery device (claim 1 of ‘939), implant holding portion being configured to retain a sheet-like implant during implantation of the sheet-like implant, wherein the implant holding portion is configured to receive the sheet-like implant between a fixed implant supporting flange member and a movable implant supporting flange member, the fixed implant support flange member associated with the outer shaft and configured to support the sheet- like implant on a first side of the sheet-like implant (claim 1 of ‘939).
‘939 does not claim wherein the fixed implant supporting flange member includes a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft.
Zenz- Olson teaches an implant delivery device (100)(Figs. 1A- 7 and Fig. 8B)(abstract), comprising: a handle (107) disposed at a proximal end of the implant delivery device (see annotated Fig. 1A below) and configured to be grasped by a user (Column 3, Lines 11- 25); an outer shaft (outer tube 102, connector 104, inner tube 110, head 113) extending from the handle to a distal end of the implant delivery device (see annotated Fig. 1A below); and an implant holding portion (sheath 103, implant positioning component 115) proximate the distal end of the implant delivery device (see annotated Fig. 1A below), the implant holding portion being configured to retain a sheet- like implant (implant 114)(Column 7, Lines 33- 49) during implantation of the sheet-like implant (Column 10, Lines 44- 58), wherein the implant holding portion is configured to receive the sheet-like implant between a fixed implant supporting flange member (implant positioning component 115)(Fig. 8F)(Column 15, Lines 46- 49) and a movable implant supporting flange member (sheath 103)(As sheath 103 is taught to move and supports the implant (Column 10, Lines 28- 43), it is considered a movable implant supporting flange member.), the fixed implant supporting flange member associated with the outer shaft (see annotated Fig. 1A below) and configured to support the sheet-like implant on a first side of the sheet-like implant, wherein the fixed implant supporting flange member includes a pair of substantially triangular-shaped wings extending from a centerline axis of the outer shaft (see annotated Fig. 8B below)(Column 10, Lines 47- 52 and Column 11, Lines 42- 45).
PNG
media_image1.png
581
1073
media_image1.png
Greyscale
PNG
media_image2.png
600
479
media_image2.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 2, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the pair of substantially triangular- shaped wings include a first wing and a second wing, the fixed implant supporting flange member having a maximum width extending from a first tip of the first wing to a second tip of the second wing (Zenz- Olson, see annotated Fig. 8B below).
PNG
media_image3.png
600
479
media_image3.png
Greyscale
Regarding claim 3, ‘939 and Zenz- Olson claim the claim limitations of claim 2 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the fixed implant supporting flange member further includes a necked- down portion at a distal end thereof, wherein the necked down portion has a width that is narrower than the maximum width extending from the first tip of the first wing to the second tip of the second wing (Zenz-Olson, see annotated Fig. 8B below).
PNG
media_image4.png
564
477
media_image4.png
Greyscale
Regarding claim 4, ‘939 and Zenz- Olson claim the claim limitations of claim 2 as discussed above.
The combination does not claim in the current embodiment wherein at least the first wing includes a proximal edge that extends at a first angle with respect to the centerline axis and a distal edge that extends at a second angle with respect to the centerline axis, the second angle being larger than the first angle.
Zenz- Olson teaches in a second embodiment a fixed implant supporting flange member (implant positioning component 115) including a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft, wherein at least the first wing includes a proximal edge that extends at a first angle with respect to the centerline axis and a distal edge that extends at a second angle with respect to the centerline axis, the second angle being larger than the first angle (see annotated Fig. 8F below)(Column 16, Lines 37- 44 and Column 17, Lines 32- 35).
PNG
media_image9.png
510
506
media_image9.png
Greyscale
It would have been obvious to one of ordinary skill in the art to modify the shape of the pair of substantially triangular- shaped wings as claimed by the combination to have the shape as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding claim 5, ‘939 and Zenz- Olson claim the claim limitations of claim 2 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the first tip of the first wing and the second tip of the second wing are substantially curved (Zenz- Olson, see annotated Fig. 8B below).
PNG
media_image5.png
371
470
media_image5.png
Greyscale
Regarding claim 6, ‘939 and Zenz- Olson claim the claim limitations of claim 2 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the first tip of the first wing and the second tip of the second wing are substantially elongated, forming elongated edges extending in a longitudinal direction in substantial alignment with the centerline axis (Zenz- Olson, see annotated Fig. 8B below).
PNG
media_image6.png
557
470
media_image6.png
Greyscale
Regarding claim 7, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the fixed implant supporting flange member includes one window in each wing of the pair of substantially triangular- shaped wings (Zenz- Olson, see annotated Fig. 8B below).
PNG
media_image7.png
546
470
media_image7.png
Greyscale
Regarding claim 8, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
The combination does not claim wherein the fixed implant supporting flange member is asymmetrical in the proximal- distal direction.
Zenz- Olson teaches in a second embodiment a fixed implant supporting flange member (implant positioning component 115) including a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft, wherein the fixed implant supporting flange member is asymmetrical in the proximal- distal direction (see annotated Fig. 8F below)( Column 16, Lines 37- 44 and Column 17, Lines 32- 35).
PNG
media_image10.png
422
499
media_image10.png
Greyscale
It would have been obvious to one of ordinary skill in the art to modify the shape of the pair of substantially triangular- shaped wings as claimed by the combination to have the shape as taught by the second embodiment of Zenz- Olson, since Zenz- Olson teaches that “any of the examples could include any of such features” (Column 16, Lines 20- 25) and that the fixed implant supporting flange member “can be shaped in any number of different configurations” (Column 15, Lines 46- 49).
Regarding claim 9, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding wherein each wing of the pair of substantially triangular- shaped wings has one edge that is concave, as Zenz- Olson teaches in Column 17, Lines 28- 32 that the implant positioned component can curve out of a plane, therefore when looking at the side of the fixed implant supporting flange member, the edge would be concave for each wing.
Regarding claim 15, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
‘939 further claims wherein the movable implant supporting flange member is configured to be slidable between a first, distal position and a second, proximal position, wherein, in the first, distal position, the movable implant supporting flange member secures the sheet-like implant against the fixed implant supporting flange member, thus holding the sheet-like implant in an unfurled configuration, and wherein, in the second, proximal position, the movable implant supporting flange member is withdrawn from the distal end of the implant delivery device, thus enabling release of the sheet-like implant (claim 1 of ‘939).
Regarding claim 16, ‘939 claims an implant delivery device, comprising: an implant holding portion proximate a distal end of the implant delivery device, the implant holding portion being configured to retain a sheet-like implant during implantation of the sheet-like implant (claim 1 of ‘939); and a fixed implant supporting flange member associated with an outer shaft of the implant delivery device (claim 1 of ‘939).
‘939 does not claim wherein the fixed implant supporting flange member includes a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft.
Zenz- Olson teaches an implant delivery device (100)(Figs. 1A- 7 and Fig. 8B)(abstract), comprising: a handle (107) disposed at a proximal end of the implant delivery device (see annotated Fig. 1A below) and configured to be grasped by a user (Column 3, Lines 11- 25); an outer shaft (outer tube 102, connector 104, inner tube 110, head 113) extending from the handle to a distal end of the implant delivery device (see annotated Fig. 1A below); and an implant holding portion (sheath 103, implant positioning component 115) proximate the distal end of the implant delivery device (see annotated Fig. 1A below), the implant holding portion being configured to retain a sheet- like implant (implant 114)(Column 7, Lines 33- 49) during implantation of the sheet-like implant (Column 10, Lines 44- 58), wherein the implant holding portion is configured to receive the sheet-like implant between a fixed implant supporting flange member (implant positioning component 115)(Fig. 8F)(Column 15, Lines 46- 49) and a movable implant supporting flange member (sheath 103)(As sheath 103 is taught to move and supports the implant (Column 10, Lines 28- 43), it is considered a movable implant supporting flange member.), the fixed implant supporting flange member associated with the outer shaft (see annotated Fig. 1A below) and configured to support the sheet-like implant on a first side of the sheet-like implant, wherein the fixed implant supporting flange member includes a pair of substantially triangular-shaped wings extending from a centerline axis of the outer shaft (see annotated Fig. 8B below)(Column 10, Lines 47- 52 and Column 11, Lines 42- 45).
PNG
media_image1.png
581
1073
media_image1.png
Greyscale
PNG
media_image2.png
600
479
media_image2.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art to modify the shape of the fixed implant supporting flange member to have a pair of substantially triangular- shaped wings extending from a centerline axis of the outer shaft as taught by Zenz- Olson for the purpose of supporting a sheet- like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one fixed implant supporting flange member for another because both flange members are disclosed as equivalent structures for supporting a sheet-like implant (‘939, claim 1; Zenz- Olson, Column 10, Lines 47- 52 and Column 11, Lines 42- 45). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 17, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
‘939 further claims the device further including a movable implant supporting flange member (claim 1 of ‘939), the implant holding portion being configured to receive the sheet-like implant between the movable implant supporting flange member and the fixed implant supporting flange member (claim 1 of ‘939).
Regarding claim 18, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
‘939 further claims wherein the fixed implant supporting flange member and the movable implant supporting flange member are flexible and resilient such that the fixed implant supporting flange member and the movable implant supporting flange member may be at least partially collapsed upon delivery through a cannula (claim 2 of ‘939).
Regarding claim 19, ‘939 and Zenz- Olson claim the claim limitations of claim 1 as discussed above.
‘939 further claims wherein the sheet-like implant is retained in a recess by the movable implant supporting flange member and the fixed implant supporting flange member (claim 9 of ‘939).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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, Jackie Ho can be reached at (571) 272- 4696. 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.
/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771