DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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).
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Claims 1, 2, 5, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 5 of U.S. Patent No. 11,872,117 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, US 11,872,117 B2 discloses an implant delivery device for delivering a sheet-like implant through a cannula (claim 1), the implant delivery device comprising: an implant holder assembly having a distal end, a proximal end and separable first and second legs each having a proximal end and a distal end, with the proximal ends of the first and second legs secured to the implant holder assembly (claim 1); wherein the first and second legs have a closed position with the legs adjacent each other, and an open position with the distal end of each leg translated away from one another in a generally transverse direction to form an open-ended implant holder assembly (claim 1); wherein when in the open position, the implant holder assembly is devoid of structure extending transverse between and connecting the first and second legs (claim 1); and at least one opening in the distal end of the implant holder assembly configured to secure a portion of the sheet-like implant (claim 1).
Regarding claim 2, US 11,872,117 B2 discloses the first and second legs are biased in the open position (claim 2).
Regarding claim 5, US 11,872,117 B2 discloses the first and second legs are configured to hold the sheet-like implant in a flat configuration (claim 5)
Regarding claim 6, US 11,872,117 B2 discloses the sheet-like implant coupled to the implant holder assembly with a first portion of the sheet-like implant secured to the at least one opening in the implant holder assembly (claim 4).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Tovey (US 5,405,360).
Regarding claim 1, Tovey discloses (Figures 1-12) an implant delivery device capable of delivering a sheet-like implant (17) through a cannula (18; NOTE: the cannula is not positively recited), the implant delivery device comprising: an implant holder assembly (13) having a distal end, a proximal end and separable first and second legs (11) each having a proximal end and a distal end, with the proximal ends of the first and second legs secured to the implant holder assembly (Column 3, lines 53-54); wherein the first and second legs have a closed position with the legs adjacent each other (Figures 3 and 4), and an open position with the distal end of each leg translated away from one another in a generally transverse direction to form an open-ended implant holder assembly (Figures 1, 2, 5, 9, 10, 12) ; wherein when in the open position, the implant holder assembly is devoid of structure extending transverse between and connecting the first and second legs (Tovey does not disclose any structure(s) extending between and connecting the first and second legs); and at least one opening (15) in the distal end of the implant holder assembly configured to secure a portion of the sheet-like implant (Column 7, line 57 – Column 8, line 2).
Regarding claim 2, Tovey discloses the first and second legs (11) are biased in the open position (Column 6, lines 34-43).
Regarding claim 3, Tovey discloses that the first and second legs comprise a superelastic material (Column 7, lines 18-42) that biases the first and second legs in the open position (Column 6, lines 34-43), wherein the legs may be forced in apposition to each other to fit into the cannula (Figures 3 and 4) and thereafter superelastically open upon exit from the distal end of the cannula (Figures 1, 2, 5, 9, 10, 12).
Regarding claim 4, Tovey discloses (Figure 5) the proximal ends of the first and second legs (11) are secured to the distal end of the implant holder assembly (Column 3, lines 53-54).
Regarding claim 5, Tovey discloses (Figure 5) the first and second legs (11) are configured to hold the sheet-like implant (17) in a flat configuration.
Regarding claim 6, Tovey discloses (Figures 1-5 and 9-12) the sheet-like implant (17) coupled to the implant holder assembly with a first portion of the sheet-like implant secured to the at least one opening (15) in the implant holder assembly (Column 7, line 57 – Column 8, line 2).
Regarding claim 7, Tovey discloses (Figures 3, 4, and 11) the cannula (18) encloses the implant holder assembly (18) and the sheet-like implant (17) with the sheet-like implant in the distal end of the cannula.
Regarding claim 8, Tovey discloses (Figures 1-12) a tube (18) having a proximal end and a distal end wherein the tube is sized to enclose the implant holder assembly (18) and the sheet-like implant (17), wherein the first and second legs (11) cause the sheet-like implant to open upon exit from the distal end of the tube (Column 8, lines 24-29).
Regarding claim 9, Tovey discloses (Figures 1-12) an implant delivery device comprising: a delivery shaft (13) having a distal end, a proximal end and a longitudinal axis; an implant holder having first and second legs (11) each having a proximal and a distal end, the proximal ends of the first and second legs secured to the delivery shaft (Column 3, lines 53-54); wherein the first and second legs have a closed position with the legs adjacent each other and extending parallel to the longitudinal axis of the delivery shaft (Figures 3, 4, and 11), and an open position with the distal end of each leg translated in a generally transverse direction to form an open-ended implant holder (Figures 1, 2, 5, 9, 10, 12); and a tube (18) having a proximal end and a distal end wherein the tube is sized to enclose the delivery shaft (13), the implant holder and a sheet-like implant (17); wherein when in the open position, the implant holder is devoid of structure extending transverse between and connecting the first and second legs (Tovey does not disclose any structure(s) extending between and connecting the first and second legs).
Regarding claim 10, Tovey discloses the first and second legs are biased in the open position (Column 6, lines 34-43).
Regarding claim 11, Tovey discloses that the first and second legs comprise a superelastic material (Column 7, lines 18-42) that biases the first and second legs in the open position (Column 6, lines 34-43), wherein the legs may be forced in apposition to each other to fit into the tube (Figures 3, 4, 11) and thereafter superelastically open upon exit from the distal end of the tube (Figures 1, 2, 5, 9, 10, 12).
Regarding claim 12, Tovey discloses (Figure 5) a slot (15) in the distal end of each of the first and second legs (11) sized and dimensioned to engage a portion of the sheet-like implant (Column 7, line 57 – Column 8, line 2).
Regarding claim 13, Tovey discloses (Figures 1-5 and 9-12) the sheet-like implant (17) coupled to the implant holder with a first portion of the sheet-like implant engaged with the slot (Column 7, line 57 – Column 8, line 2).
Regarding claim 14, Tovey discloses (Figures 1-5 and 9-12) that the first portion of the sheet-like implant (17) is engaged with the slot (15) in the first leg (11) and a second portion of the sheet-like implant is engaged with the slot in the second leg (Column 7, line 57 – Column 8, line 2).
Regarding claim 15, Tovey discloses (Figure 5) the first and second legs (11) are configured to hold the sheet-like implant (17) in a flat configuration.
Regarding claim 16, Tovey discloses (Figures 1-12) an implant delivery assembly capable of delivering a sheet-like implant (17, 22) to an arthroscopic workspace, the implant delivery assembly comprising: an implant holder (13) having a distal end, a proximal end and a plurality of separable legs (11) each having a proximal and distal end, with the proximal ends of the plurality of legs secured to the distal end of the implant holder (Column 3, lines 53-54); wherein the plurality of legs has a closed position with the legs adjacent each other (Figures 3, 4, and 11), and an open position with the distal end of each leg translated in a generally transverse direction to form an open-ended implant holder (Figures 1, 2, 5, 9, 10, 12); wherein the plurality of separable legs is biased in the open position (Column 6, lines 34-43), and when in the open position, the implant holder is devoid of structure extending transverse between and connecting at least first and second legs of the plurality of separable legs (Tovey does not disclose any structure(s) extending between and connecting the first and second legs); at least one slot (15) in the distal end of the implant holder sized and dimensioned to engage a portion of the sheet-like implant (Column 7, line 57 – Column 8, line 2); and the sheet-like implant coupled to the implant holder with a first portion of the sheet-like implant disposed within the at least one slot (Column 7, line 57 – Column 8, line 2).
Regarding claim 17, the plurality of legs comprises a superelastic material (Column 7, lines 18-42) biased to the open position (Column 6, lines 34-43), such that the legs may be forced in apposition to each other to fit into a tube (Figures 3, 4, 11) and thereafter superelastically open upon exit from the tube (Figures 1, 2, 5, 9, 10, 12).
Regarding claim 18, Tovey discloses (Figure 5) the plurality of legs (11) is configured to hold the sheet-like implant (17) in a flat configuration.
Regarding claim 19, Tovey discloses the at least one slot includes at least a first slot (15) in the distal end of the first leg (11) and at least a second slot (15) in the distal end of the second leg (11), the first and second slots sized and dimensioned to engage the portion of the sheet-like implant, wherein the first portion of the sheet-like implant is engaged with the first slot in the first leg and a second portion of the sheet-like implant is engaged with the second slot in the second leg (Column 7, line 57 – Column 8, line 2).
Regarding claim 20, Tovey discloses (Figures 3, 4, 11) a tube (180 having a proximal end and a distal end wherein the tube is sized to enclose the implant holder (13) and the sheet-like implant (17), wherein the plurality of legs causes the sheet-like implant to open upon exit from the distal end of the tube (Column 8, lines 24-29).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Henderson (US 2008/0188874 A1; Figures 1-4B), Axelson, Jr. et al. (US 2009/0012521 A1; Figures 1-11), and Montpetit et al. (US 2011/0015477 A1; Figures 11-15B) disclose similar implant delivery devices/assemblies to that of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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