DETAILED ACTION
This Office Action acknowledges the applicant’s amendment filed 25 June 2026. Claims 11-20 are pending in the application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Grabowski (WO 2013184271), in view of Tulis (DE 2404508) and McKenzie et al. (US 20190144178).
Regarding claim 11, Grabowski teaches a sterile packaging (figure 1, reference 100) for a sterile object (figure 1, reference 10 and paragraph 6), comprising: an outer packaging (figure 1, reference 102); at least one container (figure 1 and 7, reference 104) arranged in the outer packaging (figure 1), the at least one container forming a sterile barrier (paragraph 6), the at least one container forming a receiving compartment (paragraph 5: the receiving cavity is the receiving compartment) within the at least one container (paragraph 5) and includes a first recess (paragraph 5) within which the receiving compartment is formed (paragraph 5); wherein the outer packaging is formed as a prism (figure 1 and 7) with two lateral faces (figure 1 and 7, top and bottom surface of outer packaging 102) that are positioned opposite each other along a longitudinal direction of the outer packaging (figure 1) and that form a bottom face (figure 1 and 2, reference 120) and a top face (figure 1 and 2, reference 121) of the prism and with three or four rectangular lateral faces forming a lateral surface area of the prism (figure 1 and 2, reference 116, 124, 118, 110). Furthermore, Grabowski states [paragraph 6] “It is noted, however, that the box may be formed in any other shape without deviating from the scope of the invention and to conform to the shape and size of one or more medical devices housed therein”.
Grabowski does not teach the at least one container comprises a first tray closed by a peel-off first lid. However, Tulis does teach the at least one container (figure 3, reference 140) comprises a first tray (figure 3, reference 118) closed by a peel-off first lid (figure 3, reference 32).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of Grabowski to include the at least one container comprises a first tray closed by a peel-off first lid, as disclosed by Tulis, because including the a first tray closed by a peel-off first lid allows for easy access and protection of the sterile object once the outer packaging is opened.
Grabowski, in view of Tulis do not explicitly teach the lateral faces being two triangular or truncated-triangular lateral faces. However, McKenzie does teach the lateral faces being two triangular or truncated-triangular lateral faces (figure 1 and 2, reference 102 and 104).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of Grabowski, in view of Tulis, to include the lateral faces being two triangular or truncated-triangular lateral faces, as disclosed by McKenzie, because including the lateral faces being two triangular or truncated-triangular lateral faces increases the aesthetic design of the packaging and allows for the packaging to be a smaller light weight shape, as explained by McKenzie (paragraphs 33 and 34). Furthermore, to modify the lateral faces of Grabowski with the triangular lateral faces of McKenzie as claimed would entail a mere change in shape of the lateral faces and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 12, Grabowski, in view of Tulis and McKenzie, teach all of the claim limitations of claim 11, as shown above. Furthermore, Grabowski teaches the bottom face (figure 1 and 2, reference 120) and the top face (figure 1 and 2, reference 121) are formed as a prism (figure 2). Furthermore, Tulis teaches two opposite lateral lengths (figure 3, as shown in the annotated figure below) of the bottom face and the top face (figure 3 is a side profile showing the shape of the bottom or top surface) have different lengths (figure 3, as shown in the annotated figure below: L1 is smaller than L2) such that one of the lateral lengths (figure 3, as shown in the annotated figure below: L2) is longer than the of the other lateral length (figure 3, as shown in the annotated figure below: L1). Furthermore, McKenzie teaches the bottom face and top face being triangular (figure 1 and 2, reference 102 and 104).
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Grabowski, in view of Tulis and McKenzie, do not explicitly teach the bottom face and the top face formed as a truncated-triangular prism or one of the lateral lengths is at least three times as long as that of the other lateral lengths. However, to modify the bottom face and the top with the truncated-triangular prism as claimed would entail a mere change in shape of faces and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, it has been held that, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than a prior art device, the claimed device is not patentably distinct from the prior art device. Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of modified Grabowski to have the bottom face and the top face formed as a truncated-triangular prism or one of the lateral lengths is at least three times as long as that of the other lateral lengths because having one of the lengths at least three times as long as another length would allow for holding an object that is much wider on one side then it is on the other side.
Regarding claim 13, Grabowski, in view of Tulis and McKenzie, teach all of the claim limitations of claim 11, as shown above. Furthermore, Tulis teaches the bottom face and the top face are substantially triangular shaped. Although, Tulis does not explicitly teach the bottom face and the top face are shaped as a triangle, to modify the top and bottom face with a triangular shape as claimed would entail a mere change in shape of top and bottom face and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 14, Grabowski, in view of Tulis and McKenzie, teach all of the claim limitations of claim 13, as shown above. Furthermore, Tulis teaches the bottom face and the top face are shaped substantially as a right-angled triangle. Although, Tulis does not explicitly teach the bottom face and the top face shaped as a right-angled triangle, to modify the top and bottom face with a right-angled triangle as claimed would entail a mere change in shape of top and bottom face and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 15, Grabowski, in view of Tulis and McKenzie, teach all of the claim limitations of claim 11, as shown above. Furthermore, Grabowski teaches one or both of: the outer packaging comprises a predetermined breaking point line (figure 1, reference 136) for opening the outer packaging (paragraph 11); and the outer packaging comprises a transparent window (figure 1, reference 112).
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Grabowski (WO 2013184271), in view of Tulis (DE 2404508) and Sharon (US 7,967,154).
Regarding claim 11, Grabowski teaches a sterile packaging (figure 1, reference 100) for a sterile object (figure 1, reference 10 and paragraph 6), comprising: an outer packaging (figure 1, reference 102); at least one container (figure 1 and 7, reference 104) arranged in the outer packaging (figure 1), the at least one container forming a sterile barrier (paragraph 6), the at least one container forming a receiving compartment (paragraph 5: the receiving cavity is the receiving compartment) within the at least one container (paragraph 5) and includes a first recess (paragraph 5) within which the receiving compartment is formed (paragraph 5); wherein the outer packaging is formed as a prism (figure 1 and 7) with two lateral faces (figure 1 and 7, top and bottom surface of outer packaging 102) that are positioned opposite each other along a longitudinal direction of the outer packaging (figure 1) and that form a bottom face (figure 1 and 2, reference 120) and a top face (figure 1 and 2, reference 121) of the prism and with three or four rectangular lateral faces forming a lateral surface area of the prism (figure 1 and 2, reference 116, 124, 118, 110). Furthermore, Grabowski states [paragraph 6] “It is noted, however, that the box may be formed in any other shape without deviating from the scope of the invention and to conform to the shape and size of one or more medical devices housed therein”.
Grabowski does not teach the at least one container comprises a first tray closed by a peel-off first lid. However, Tulis does teach the at least one container (figure 3, reference 140) comprises a first tray (figure 3, reference 118) closed by a peel-off first lid (figure 3, reference 32).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of Grabowski to include the at least one container comprises a first tray closed by a peel-off first lid, as disclosed by Tulis, because including the a first tray closed by a peel-off first lid allows for easy access and protection of the sterile object once the outer packaging is opened.
Grabowski, in view of Tulis do not explicitly teach the lateral faces being two triangular or truncated-triangular lateral faces. However, Sharon does teach the lateral faces being two triangular or truncated-triangular lateral faces (figure 3, reference 13 on either side).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of Grabowski, in view of Tulis, to include the lateral faces being two triangular or truncated-triangular lateral faces, as disclosed by Sharon, because including the lateral faces being two triangular or truncated-triangular lateral faces increases the aesthetic design of the packaging and allows for the packaging stand properly. Furthermore, to modify the lateral faces of Grabowski with the truncated-triangular lateral faces of Sharon as claimed would entail a mere change in shape of the lateral faces and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 12, Grabowski, in view of Tulis and Sharon, teach all of the claim limitations of claim 11, as shown above. Furthermore, Grabowski teaches the bottom face (figure 1 and 2, reference 120) and the top face (figure 1 and 2, reference 121) are formed as a prism (figure 2). Furthermore, Tulis teaches two opposite lateral lengths (figure 3, as shown in the annotated figure below) of the bottom face and the top face (figure 3 is a side profile showing the shape of the bottom or top surface) have different lengths (figure 3, as shown in the annotated figure below: L1 is smaller than L2) such that one of the lateral lengths (figure 3, as shown in the annotated figure below: L2) is longer than the of the other lateral length (figure 3, as shown in the annotated figure below: L1). Furthermore, Sharon teaches the bottom face and the top face are formed as a truncated triangular prism (figure 3, reference 13).
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Grabowski, in view of Tulis and Sharon, do not explicitly teach one of the lateral lengths is at least three times as long as that of the other lateral lengths. However, it has been held that, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than a prior art device, the claimed device is not patentably distinct from the prior art device. Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of modified Grabowski to have one of the lateral lengths is at least three times as long as that of the other lateral lengths because having one of the lengths at least three times as long as another length would allow for holding an object that is much wider on one side then it is on the other side.
Regarding claim 13, Grabowski, in view of Tulis and Sharon, teach all of the claim limitations of claim 11, as shown above. Furthermore, Tulis teaches the bottom face and the top face are substantially triangular shaped. Although, Tulis does not explicitly teach the bottom face and the top face are shaped as a triangle, to modify the top and bottom face with a triangular shape as claimed would entail a mere change in shape of top and bottom face and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 14, Grabowski, in view of Tulis and Sharon, teach all of the claim limitations of claim 13, as shown above. Furthermore, Tulis teaches the bottom face and the top face are shaped substantially as a right-angled triangle. Although, Tulis does not explicitly teach the bottom face and the top face shaped as a right-angled triangle, to modify the top and bottom face with a right-angled triangle as claimed would entail a mere change in shape of top and bottom face and yield only predictable results. "[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR Int 'l v. Teleflex Inc., 127 S.Ct. 1740, 82 USPQ2d 1396 (2007). A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 15, Grabowski, in view of Tulis and Sharon, teach all of the claim limitations of claim 11, as shown above. Furthermore, Grabowski teaches one or both of: the outer packaging comprises a predetermined breaking point line (figure 1, reference 136) for opening the outer packaging (paragraph 11); and the outer packaging comprises a transparent window (figure 1, reference 112).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grabowski (WO 2013184271), in view of Tulis (DE 2404508) and McKenzie et al. (US 20190144178), as applied to claim 11 above, and further in view of Kapec et al. (US 10,828,141).
Regarding claim 16, Grabowski, in view of Tulis and McKenzie, teach all of the claim limitations of claim 13, as shown above.
Grabowski, in view of Tulis and McKenzie, do not explicitly teach the at least one container comprises an outer container forming a first sterile barrier and the receiving compartment forms a first receiving compartment; the at least one container further comprises an inner container arranged in the first receiving compartment, forms a second sterile barrier, and forms a second receiving compartment, the outer container comprises a first tray closed by a peel-off first cover with a first recess in which the first receiving compartment is positioned; the inner container comprises a second tray closed by a peel-off second cover with a second recess in which the second receiving compartment is positioned; and the second recess comprises an indentation that rests on a surface of the first recess in the first receiving compartment and is configured as a pivotal point for a tilting movement of the inner container relative to the outer container. However, Kapec does teach the at least one container (figure 1, reference 10) comprises an outer container (figure 1, reference 12/14) forming a first sterile barrier (column 2, lines 61-62) and the receiving compartment forms a first receiving compartment (figure 1, reference 24); the at least one container further comprises an inner container (figure 1, reference 16/18) arranged in the first receiving compartment (figure 2), forms a second sterile barrier (column 3, lines 46-47), and forms a second receiving compartment (figure 1, reference 30), the outer container comprises a first tray (figure 1, reference 12) closed by a peel-off first cover (figure 1, reference 14) with a first recess in which the first receiving compartment is positioned (figure 1, reference 24); the inner container comprises a second tray (figure 1, reference 16) closed by a peel-off second cover (figure 1, reference 18) with a second recess in which the second receiving compartment is positioned (figure 1, reference 30); and the second recess comprises an indentation (figure 1, reference 32) that rests on a surface of the first recess in the first receiving compartment (figure 2) and is capable of being configured as a pivotal point for a tilting movement of the inner container relative to the outer container (figure 2: This limitation has been treated as an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Since the limitation has not been positively claimed, the system of Kapec is capable of performing the recited function).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of modified Grabowski to include the at least one container comprises an outer container forming a first sterile barrier and the receiving compartment forms a first receiving compartment; the at least one container further comprises an inner container arranged in the first receiving compartment, forms a second sterile barrier, and forms a second receiving compartment, the outer container comprises a first tray closed by a peel-off first cover with a first recess in which the first receiving compartment is positioned; the inner container comprises a second tray closed by a peel-off second cover with a second recess in which the second receiving compartment is positioned; and the second recess comprises an indentation that rests on a surface of the first recess in the first receiving compartment and is configured as a pivotal point for a tilting movement of the inner container relative to the outer container, as disclosed by Kapec, because including the outer and inner containers with respective lids allows for holding medical objects in preserved stets prior to use, as explained by Kapec (column 2, lines 15-27).
Regarding claim 17, Grabowski, in view of Tulis, McKenzie and Kapec, teach all of the claim limitations of claim 16, as shown above. Furthermore, Kapec teaches the first tray comprises a peripheral edge section (figure 1, reference 28) that surrounds the first recess (figure 1, reference 24) and to which the peel-off first cover is attached (figure 1 and 2, reference 28); and the second tray comprises a peripheral edge section (figure 1, reference 34) that surrounds the second recess (figure 1, reference 30) and to which the peel-off second cover is attached (figure 1 and 2, reference 28).
Regarding claim 18, Grabowski, in view of Tulis, McKenzie and Kapec, teach all of the claim limitations of claim 16, as shown above. Furthermore, Kapec teaches the sterile packaging extends along the longitudinal direction (figure 2 and 6); the first tray features a first end section for holding the outer container (figure 1, reference 29) and a second end section opposite the first end section in the longitudinal direction (figure 1, opposite end of first tray 12 near reference 24); the first recess is formed in the longitudinal direction between the first end section and the second end section (figure 1, reference 24); and a thinned section is formed between the second end section and the first recess to allow for creasing of the second end section (figure 1: the space between the end of first tray 12 near 29 and reference 24a is a thinned section).
Regarding claim 19, Grabowski, in view of Tulis, McKenzie and Kapec, teach all of the claim limitations of claim 16, as shown above. Furthermore, Kapec teaches a carrier (figure 1, reference 20) is arranged in the second receiving compartment (figure 2) and comprises a shaped part (figure 1, reference 46) with a third receiving compartment (figure 1 and 3, reference 48) for the sterile object (figure 3, reference 22).
Regarding claim 20, Grabowski, in view of Tulis, McKenzie and Kapec, teach all of the claim limitations of claim 19, as shown above. Furthermore, Kapec teaches one or both of: the shaped part exerts a clamping action on the sterile object (figure 1: when the shaped part 20 is placed in second cavity 30, it creates a clamping action on sterile object 22 as seen in figure 4); and the sterile object is capable of being a bone screw (This limitation has been treated as an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Since the limitation has not been positively claimed, the system of Kapec is capable of performing the recited function).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grabowski (WO 2013184271), in view of Tulis (DE 2404508) and Sharon (US 7,967,154), as applied to claim 11 above, and further in view of Kapec et al. (US 10,828,141).
Regarding claim 16, Grabowski, in view of Tulis and Sharon, teach all of the claim limitations of claim 13, as shown above.
Grabowski, in view of Tulis and Sharon, do not explicitly teach the at least one container comprises an outer container forming a first sterile barrier and the receiving compartment forms a first receiving compartment; the at least one container further comprises an inner container arranged in the first receiving compartment, forms a second sterile barrier, and forms a second receiving compartment, the outer container comprises a first tray closed by a peel-off first cover with a first recess in which the first receiving compartment is positioned; the inner container comprises a second tray closed by a peel-off second cover with a second recess in which the second receiving compartment is positioned; and the second recess comprises an indentation that rests on a surface of the first recess in the first receiving compartment and is configured as a pivotal point for a tilting movement of the inner container relative to the outer container. However, Kapec does teach the at least one container (figure 1, reference 10) comprises an outer container (figure 1, reference 12/14) forming a first sterile barrier (column 2, lines 61-62) and the receiving compartment forms a first receiving compartment (figure 1, reference 24); the at least one container further comprises an inner container (figure 1, reference 16/18) arranged in the first receiving compartment (figure 2), forms a second sterile barrier (column 3, lines 46-47), and forms a second receiving compartment (figure 1, reference 30), the outer container comprises a first tray (figure 1, reference 12) closed by a peel-off first cover (figure 1, reference 14) with a first recess in which the first receiving compartment is positioned (figure 1, reference 24); the inner container comprises a second tray (figure 1, reference 16) closed by a peel-off second cover (figure 1, reference 18) with a second recess in which the second receiving compartment is positioned (figure 1, reference 30); and the second recess comprises an indentation (figure 1, reference 32) that rests on a surface of the first recess in the first receiving compartment (figure 2) and is capable of being configured as a pivotal point for a tilting movement of the inner container relative to the outer container (figure 2: This limitation has been treated as an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Since the limitation has not been positively claimed, the system of Kapec is capable of performing the recited function).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of modified Grabowski to include the at least one container comprises an outer container forming a first sterile barrier and the receiving compartment forms a first receiving compartment; the at least one container further comprises an inner container arranged in the first receiving compartment, forms a second sterile barrier, and forms a second receiving compartment, the outer container comprises a first tray closed by a peel-off first cover with a first recess in which the first receiving compartment is positioned; the inner container comprises a second tray closed by a peel-off second cover with a second recess in which the second receiving compartment is positioned; and the second recess comprises an indentation that rests on a surface of the first recess in the first receiving compartment and is configured as a pivotal point for a tilting movement of the inner container relative to the outer container, as disclosed by Kapec, because including the outer and inner containers with respective lids allows for holding medical objects in preserved stets prior to use, as explained by Kapec (column 2, lines 15-27).
Regarding claim 17, Grabowski, in view of Tulis, Sharon and Kapec, teach all of the claim limitations of claim 16, as shown above. Furthermore, Kapec teaches the first tray comprises a peripheral edge section (figure 1, reference 28) that surrounds the first recess (figure 1, reference 24) and to which the peel-off first cover is attached (figure 1 and 2, reference 28); and the second tray comprises a peripheral edge section (figure 1, reference 34) that surrounds the second recess (figure 1, reference 30) and to which the peel-off second cover is attached (figure 1 and 2, reference 28).
Regarding claim 18, Grabowski, in view of Tulis, Sharon and Kapec, teach all of the claim limitations of claim 16, as shown above. Furthermore, Kapec teaches the sterile packaging extends along the longitudinal direction (figure 2 and 6); the first tray features a first end section for holding the outer container (figure 1, reference 29) and a second end section opposite the first end section in the longitudinal direction (figure 1, opposite end of first tray 12 near reference 24); the first recess is formed in the longitudinal direction between the first end section and the second end section (figure 1, reference 24); and a thinned section is formed between the second end section and the first recess to allow for creasing of the second end section (figure 1: the space between the end of first tray 12 near 29 and reference 24a is a thinned section).
Regarding claim 19, Grabowski, in view of Tulis, Sharon and Kapec, teach all of the claim limitations of claim 16, as shown above. Furthermore, Kapec teaches a carrier (figure 1, reference 20) is arranged in the second receiving compartment (figure 2) and comprises a shaped part (figure 1, reference 46) with a third receiving compartment (figure 1 and 3, reference 48) for the sterile object (figure 3, reference 22).
Regarding claim 20, Grabowski, in view of Tulis, Sharon and Kapec, teach all of the claim limitations of claim 19, as shown above. Furthermore, Kapec teaches one or both of: the shaped part exerts a clamping action on the sterile object (figure 1: when the shaped part 20 is placed in second cavity 30, it creates a clamping action on sterile object 22 as seen in figure 4); and the sterile object is capable of being a bone screw (This limitation has been treated as an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Since the limitation has not been positively claimed, the system of Kapec is capable of performing the recited function).
Response to Arguments
Applicant’s arguments with respect to claims 11-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to the art rejections, in accordance with MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, 367 F.3d 1359, 70 USPQ2D 1827, 1834 (Fed. Cir. 2004).
Regarding claim 11, applicant states “Independent claim 11 currently recites "the outer packaging (1) is formed as a prism with two triangular or truncated-triangular lateral faces (la, lb)." Neither Grabowski nor Tulis, alone or in combination, teach or suggest at least the above recited portion of independent claim 11. As noted in the present application at 8 and 10, the claimed shaping of the outer packaging allows the outer packaging to be made particularly stable and/or allow for a high packing density when stacking several sterile packages”. Although Grabowski nor Tulis disclose the new limitations, McKenzie and Sharon do teach the limitations, as shown in the rejection above. Therefore, the claims remain rejected.
On page 8, lines 9-11 of the applicants’ response, the applicant states “Applicant submits the one of ordinary skill in the art would have no reason to modify Grabowski in view of Tulis to arrive at the arrangement of independent claim 14 absent impermissible hindsight”. It appears the applicant intended to say “independent claim 11” instead of “independent claim 14” and the examiner will treat it as such.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Since the prior art discloses the claim limitations, the claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clements et al. (US 20060113215) discloses a packaging with an outer packaging having opposing triangular lateral faces.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAVIER A PAGAN whose telephone number is (571)270-7719. The examiner can normally be reached Monday - Thursday: 6:30am-4:30pm.
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, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER A PAGAN/Primary Examiner, Art Unit 3735
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