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 .
In view of the appeal brief filed on 11/07/2025, PROSECUTION IS HEREBY REOPENED. A new non-final rejection of the claims is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771
Response to Arguments
Applicant’s arguments provided in an appeal brief filed 11/07/2025, with respect to the rejection(s) of claim(s) 10, 18-20, 26 and claims dependent therefrom under Fujimoto, Huang, Riley, Pulapura and Stankus have been fully considered and are persuasive. Therefore, the rejection has been withdrawn and a new non-final rejection is issued herewith. However, upon further consideration, a new ground(s) of rejection is made in view of Pulapura (previously of record) and Riley (previously of record) in an updated rejection provided below.
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.
Claim(s) 10 and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulapura (US 2017/0319754 A1) in view of Riley (US 2006/0011506 A1)(previously of record).
Regarding claim 10, Pulapura discloses:
A surgical system comprising:
a surgical device (see Fig. 6) comprising a substrate (component 22, see Fig. 6), the substrate comprising a first piece (first piece 22a, see Examiner’s Diagram of Fig. 6 below) and a second piece (second piece 22b, see Examiner’s Diagram of Fig. 6 below) that is joined with the first piece (see Fig. 6; see also Para. [0073]), the first piece and the second piece forming a pocket having a second cavity (cavity “C”, see Fig. 6 and Para. [0073]) and a second opening (opening “O”, see Fig. 6 and Para. [0073]) that is in communication with the second cavity (see Fig. 6 and Para. [0073]);
wherein the substrate is a mesh and/or a thin walled structure (see Para. [0085]-[0086]) having a thickness of 0.001 inches to 0.1 inches (see Para. [0086]).
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Examiner’s Diagram of Fig. 6
However, Pulapura does not expressly disclose:
a package comprising:
a body having a side wall including opposite top and bottom ends, the body comprising a bottom wall coupled to the bottom end, inner surfaces of the side wall and the bottom wall defining a first cavity, the top end of the side wall defining a first opening that is in communication with the first cavity, and an insert extending from the bottom wall such that the insert is positioned in the first cavity, the insert having a size and shape; and
wherein the surgical device is pre-formed such that a size and shape of the second cavity conforms to the size and shape of the insert when the surgical device is positioned in the first cavity; and
wherein the insert is configured to maintain the size and shape of the second cavity when the surgical device is positioned in the first cavity and the insert is positioned in the second cavity.
In the same field of endeavor, namely packing devices for surgical equipment, Riley teaches:
A surgical instrument package (kit tray 1 , see Figs. 1A-1C) comprising:
A body (exterior shell of kit tray 1, see Figs. 1A-1C) including four side walls having top and bottom ends (see Figs. 1A-1C) and opposing top and bottom walls connected to the four side walls (see Figs. 1A-1C; the top/lid is shown in Figs. 2A-2B per Para. [0032]-[0033]; the surgical kit tray also inherently comprises a top wall so as to retain surgical devices therein prior to use) defining a first cavity disposed between and within the four side wall and opposing top and bottom walls (see Figs. 1A-1C); the top ends of the side walls defining a first opening that is in communication with the first cavity (see Figs. 1A-1B showing wherein an opening is defined at the “top” of the kit tray housing which allows access to the inner storage lumen of the container) and a plurality of inserts (protrusions 21, see Figs. 1A-1C) extending from the bottom wall (see Figs. 1A-1B) such that the inserts are positioned in the first cavity (see Figs. 1A-1B), the inserts having a size and shape (see Figs. 1A-1B); and
One or more surgical devices (see Para. [0029] mentioning a plurality of “kit contents” surgical devices configured to be stored within the kit tray packaging) having a pocket defining a second cavity and associated opening therein that is configured to be inserted onto one of the plurality of inserts such that the insert forms a fitted connected within the internal pocket of the surgical device (see Para. [0029] mentioning wherein one of the surgical devices stored within the kit tray packaging may have cavities to allow insertion of the one or more protrusions into the device to form a loose fit with said object) wherein the pocket of the surgical device therefore comprises a shape that is pre-formed to be fitted onto the one or more protrusions (see Para. [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Pulapura to comprise a package container comprising four side walls, a bottom wall and a top wall defining an internal cavity within the package container; the package further comprising at least one protruding insert extending radially upward from the bottom wall into the internal cavity of the package container configured to be inserted within the cavity of the surgical mesh of Pulapura as taught and suggested by Riley to, in this case, provide a sealed storage container for the surgical device of Pulapura prior to use (see Riley Para. [0029]).
While Riley teaches wherein the protrusions can have any desired width, length, height and/or geometric shape to allow the protrusions to be placed inside a desired object to allow for secure storage of the desired items (see Para. [0029]), Riley does not expressly disclose:
wherein the surgical device is pre-formed such that a size and shape of the second cavity conforms to the size and shape of the insert when the surgical device is positioned in the first cavity; and
wherein the insert is configured to maintain the size and shape of the second cavity when the surgical device is positioned in the first cavity and the insert is positioned in the second cavity.
However, since Riley discloses that the protrusions can have and desired width, length, length and/or geometric shape to allow the protrusions to be placed inside a desired object to allow for secure storage of the desired item (see Riley Para. [0029]), it would have been obvious to one of ordinary skill in the art to have modified the protrusions of Riley to be sized and shaped to conform to the second cavity of the surgical mesh of Pulapura such that the protrusion maintains the size and shape of the second cavity when the surgical mesh is positioned in the first cavity and the protrusion is positioned in the second cavity in order to secure the surgical mesh of Pulapura onto the protrusion of the package of Riley.
Regarding claim 12, the combination of Pulapura and Riley disclose the invention of claim 10, Pulapura, as modified by Riley, further discloses wherein the insert is positioned in the second cavity (the surgical mesh of Pulapura is positioned over the protrusion insert of the container of Riley to effective store the mesh within the storage container, see Riley Para. [0029]).
Regarding claim 13, the combination of Pulapura and Riley disclose the invention of claim 10, Pulapura, as modified by Riley, further discloses wherein the insert is positioned in the second cavity (see Riley Para. [0029]]) such that an outer surface of the insert directly engages an inner surface of the pocket, the inner surface defining the second cavity (the protrusion of Riley is modified (see rejection of Claim 10 above), as a matter of obviousness, to be sized and shaped such that the protrusion conforms to the size and shape of the cavity of the surgical mesh of Pulapura to more effectively store and secure the mesh device; since the surgical mesh is a non-rigid device, the protrusion of Riley being of conforming size and shape would allow the surgical mesh to be effectively stored in its intended shape).
Regarding claim 14, the combination of Pulapura and Riley disclose the invention of claim 10, Pulapura, as modified by Riley, further discloses wherein the insert is positioned in the second cavity such that an entire outer surface of the insert directly engages an inner surface of the pocket, the inner surface defining the second cavity (the protrusion of Riley is modified (see rejection of Claim 10 above), as a matter of obviousness, to be sized and shaped such that the protrusion conforms to the size and shape of the cavity of the surgical mesh of Pulapura to more effectively store and secure the mesh device due to the direct abutting contact between the two components; since the surgical mesh is a non-rigid device, the protrusion of Riley being of conforming size and shape to be in direct engagement with the internal cavity of the surgical mesh would allow the surgical mesh to be effectively stored in its intended shape).
Regarding claim 15, the combination of Pulapura and Riley disclose the invention of claim 10, Pulapura, as modified by Riley, further discloses wherein the size and shape of the insert is defined by opposite first and second side walls of the insert that each extend from a top wall of the insert to an opposite bottom wall of the insert (Riley Figs. 1A-1B showing wherein each insert comprises side walls extending between a top and bottom wall of the protrusions).
However, while Riley discloses wherein the protrusions may comprise any size or geometric shape to accommodate a desired object (see Riley Para. [0029]), the combination, as currently presented, does not expressly disclose wherein the top wall of the insert is convexly curved from the first side wall to the second side wall.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) to have obtained the predictable result of having the top surface of the protrusion of Riley have a convex, rounded shape as suggested to be an obvious modification in changing the shape of a portion of the protrusion(s) by Riley because Riley indicates that the top surface of the protrusions in a surgical equipment storage case configured to be inserted into said surgical equipment may have any size or configuration to store a desired piece of equipment, including a rounded tip as shown in Riley Fig. 2C (see Riley Para. [0029]). The term “may”, pertaining to the varied geometric size/shape of the protrusions of Riley indicates that the size and configuration are not important features and one of ordinary skill in the art would have been able to alter and change the size and configuration of the protrusion of Riley to have a rounded tip to better fit into a pocket of a desired piece of surgical equipment.
Regarding claim 16, the combination of Pulapura and Riley disclose all of the limitations of the invention of claim 15.
However, while Riley shows wherein the first and second side walls of the protrusions are “substantially parallel” to one-another, Riley does not disclose wherein the first and second side walls are parallel to one-another.
Since Riley teaches wherein the size and shape of the protrusions may be varied to have any size or geometric shape to accommodate a desired surgical object (see Riley Para. [0029]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) to have obtained the predictable result of having the side walls of the protrusion of Riley to be parallel to each opposing side wall as suggested by Riley because Riley indicates that size and shape of protrusions in a surgical equipment storage case configured to be inserted into said surgical equipment may have any size or configuration to store a desired piece of equipment, seen to include parallel side walls (see Riley Para. [0029]). The term “may”, as pertaining to the varied size and shape of the protrusions of Riley, indicates that the size and shape configuration are not important features and one of ordinary skill in the art would have been able to alter and shape of the protrusion of Riley to have side walls that are parallel to one-another with an expectation that the protrusion would still operate properly unless otherwise stated by Riley.
Regarding claim 17, the combination of Pulapura and Riley disclose all of the limitations of the invention of claim 16, Pulapura, as modified by Riley, further discloses wherein the insert includes opposite front and back walls that each extend from the top wall to the bottom wall of the insert and from the first side wall to the second side wall (Riley Figs. 1A-1B showing wherein the protrusions have four side walls extending between a top and bottom of the protrusion body), the front wall extending parallel to the back wall from the top wall to the bottom wall of the insert (each opposing side wall of the protrusions of Riley have been modified, as a matter of obviousness, to be parallel to each other per the rejection of Claim 16 above).
Claim(s) 18-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pulapura (US 2017/0319754 A1)(previously of record) in view of Riley (US 2006/0011506 A1)(previously of record), further in view of Lecuivre (US 2013/0345728 A1).
Regarding claim 18, the combination of Pulapura and Riley disclose all of the limitations of the invention of claim 10, Pulapura further discloses wherein the device comprises a coating that covers at least a portion of the substrate (see Para. [0104]), the coating comprising collagen (see Para. [0093] mentioning wherein the hemostatic coating may comprise collagen) and a hemostatic agent (see Para. [0093] mentioning wherein the coating may comprise tranexamic acid (a hemostatic agent) in addition to collagen).
However, Pulapura does not expressly disclose wherein the coating comprises glycerin.
In the same field of endeavor, namely mesh prosthesis devices designed to limit foreign body reactions when implanted in the body of a patient, Lecuivre teaches an implantable surgical mesh device (see Para. [0007]-[0009)] comprising a coating that is anti-adhesion to avoid post-surgical fibrotic adhesions (see Para. [0045] and [0049]); wherein said coating is comprised of collagen and glycerin (see Para. [0049] and [0052] mentioning wherein glycerin/glycerol may be the glycol of choice).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the coating of Pulapura to be comprised of tranexamic acid (as the hemostatic component), collagen and glycerin as taught and suggested by Lecuivre. The choice would have been obvious because Pulapura teaches both collagen and tranexamic acid as envisioned hemostatic agents can be employed in combination (see Pulapura Para. [0093]), while Lecuivre teaches that collagen, when combined with glycerol as a coating, provides surgical mesh devices with anti-adhesive properties (see Lecuivre Para. [0045], [0049] and [0052]).
Regarding claim 19, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 18, Pulapura, as modified by Lecuivre, further discloses wherein the hemostatic agent is trans- 4-(aminomethyl)cyclohexanecarboxylic acid (C8H15NO2) (see Pulapura Para. [0093] mentioning the use of tranexamic acid, which is another name for trans- 4-(aminomethyl)cyclohexanecarboxylic acid).
Regarding claim 20, Pulapura discloses:
A surgical system comprising:
a surgical device (see Fig. 6) comprising a substrate (component 22, see Fig. 6), the substrate comprising a first piece (first piece 22a, see Examiner’s Diagram of Fig. 6 below) and a second piece (second piece 22b, see Examiner’s Diagram of Fig. 6 below) that is joined with the first piece (see Fig. 6; see also Para. [0073]), the first piece and the second piece forming a pocket having a second cavity (cavity “C”, see Fig. 6 and Para. [0073]) and a second opening (opening “O”, see Fig. 6 and Para. [0073]) that is in communication with the second cavity (see Fig. 6 and Para. [0073]);
the device comprises a coating that covers at least a portion of the substrate (see Para. [0104]), the coating consisting of collagen (see Para. [0093] mentioning wherein the hemostatic coating may comprise collagen) and trans-4- (aminomethyl)cyclohexanecarboxylic acid (C8H15NO2) (see Pulapura Para. [0093] mentioning the use of tranexamic acid, which is another name for trans- 4-(aminomethyl)cyclohexanecarboxylic acid).
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Examiner’s Diagram of Fig. 6
However, Pulapura does not expressly disclose:
a package comprising:
a body having a side wall including opposite top and bottom ends, the body comprising a bottom wall coupled to the bottom end, inner surfaces of the side wall and the bottom wall defining a first cavity, the top end of the side wall defining a first opening that is in communication with the first cavity, and
an insert extending from the bottom wall such that the insert is positioned in the first cavity, the insert having a size and shape defined by opposite first and second side walls of the insert that each extend from a top wall of the insert to an opposite bottom wall of the insert, the top wall being convexly curved from the first side wall to the second side wall, the first side wall extending parallel to the second side wall from the top wall to the bottom wall of the insert, the insert including opposite front and back walls that each extend from the top wall to the bottom wall of the insert and from the first side wall to the second side wall, the front wall extending parallel to the back wall from the top wall to the bottom wall of the insert;
the device being pre-formed such that a size and shape of the second cavity conforms to the size and shape of the insert; and
wherein the coating comprises glycerin.
In the same field of endeavor, namely packing devices for surgical equipment, Riley teaches:
A surgical instrument package (kit tray 1 , see Figs. 1A-1C) comprising:
A body (exterior shell of kit tray 1, see Figs. 1A-1C) including four side walls having top and bottom ends (see Figs. 1A-1C) and opposing top and bottom walls connected to the four side walls (see Figs. 1A-1C; the top/lid is shown in Figs. 2A-2B per Para. [0032]-[0033]; the surgical kit tray also inherently comprises a top wall so as to retain surgical devices therein prior to use) defining a first cavity disposed between and within the four side wall and opposing top and bottom walls (see Figs. 1A-1C); the top ends of the side walls defining a first opening that is in communication with the first cavity (see Figs. 1A-1B showing wherein an opening is defined at the “top” of the kit tray housing which allows access to the inner storage lumen of the container) and a plurality of inserts (protrusions 21, see Figs. 1A-1C) extending from the bottom wall (see Figs. 1A-1B) such that the inserts are positioned in the first cavity (see Figs. 1A-1B), the inserts having a size and shape (see Figs. 1A-1B); and
One or more surgical devices (see Para. [0029] mentioning a plurality of “kit contents” surgical devices configured to be stored within the kit tray packaging) having a pocket defining a second cavity and associated opening therein that is configured to be inserted onto one of the plurality of inserts such that the insert forms a fitted connected within the internal pocket of the surgical device (see Para. [0029] mentioning wherein one of the surgical devices stored within the kit tray packaging may have cavities to allow insertion of the one or more protrusions into the device to form a loose fit with said object) wherein the pocket of the surgical device therefore comprises a shape that is pre-formed to be fitted onto the one or more protrusions (see Para. [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Pulapura to comprise a package container comprising four side walls, a bottom wall and a top wall defining an internal cavity within the package container; the package further comprising at least one protruding insert extending radially upward from the bottom wall into the internal cavity of the package container configured to be inserted within the cavity of the surgical mesh of Pulapura as taught and suggested by Riley to, in this case, provide a sealed storage container for the surgical device of Pulapura prior to use (see Riley Para. [0029]).
While Riley teaches wherein the protrusions can have any desired width, length, height and/or geometric shape to allow the protrusions to be placed inside a desired object to allow for secure storage of the desired items (see Para. [0029]), Riley does not expressly disclose:
Wherein the top wall of the insert is convexly curved from the first side wall to the second side wall of the insert, the first side wall of the insert extending parallel to the second side wall of the insert from the top wall to the bottom wall of the insert, the insert including opposite front and back walls that each extend from the top wall to the bottom wall of the insert and from the first side wall to the second side wall, the front wall extending parallel to the back wall from the top wall to the bottom wall of the insert;
the device being pre-formed such that a size and shape of the second cavity conforms to the size and shape of the insert.
However, since Riley discloses that the protrusions can have and desired width, length, length and/or geometric shape to allow the protrusions to be placed inside a desired object to allow for secure storage of the desired item (see Riley Para. [0029]), it would have been obvious to one of ordinary skill in the art to have modified the protrusions of Riley to be sized and shaped to conform to the second cavity of the surgical mesh of Pulapura such that the protrusion maintains the size and shape of the second cavity when the surgical mesh is positioned in the first cavity and the protrusion is positioned in the second cavity in order to secure the surgical mesh of Pulapura onto the protrusion of the package of Riley.
Since Riley teaches wherein the size and shape of the protrusions may be varied to have any size or geometric shape to accommodate a desired surgical object (see Riley Para. [0029]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) to have obtained the predictable result of modifying the top surface of the protrusion of Riley have a convex, rounded shape while modifying pairs of opposing side walls be parallel to one-another as a matter of obviousness for one of ordinary skill in the art. The term “may”, as pertaining to any desired shape/size of the protrusions, indicates that the size/shape and configuration of the protrusions are not important features of the protrusion of Riley and one of ordinary skill in the art would have been able to alter and change the size and configuration of the protrusions of Riley without departing from the scope or functionality of the protrusions.
In the same field of endeavor, namely mesh prosthesis devices designed to limit foreign body reactions when implanted in the body of a patient, Lecuivre teaches an implantable surgical mesh device (see Para. [0007]-[0009)] comprising a coating that is anti-adhesion to avoid post-surgical fibrotic adhesions (see Para. [0045] and [0049]); wherein said coating is comprised of collagen and glycerin (see Para. [0049] and [0052] mentioning wherein glycerin/glycerol may be the glycol of choice).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the coating of Pulapura to be comprised of tranexamic acid (as the hemostatic component), collagen and glycerin as taught and suggested by Lecuivre. The choice would have been obvious because Pulapura teaches both collagen and tranexamic acid as envisioned hemostatic agents can be employed in combination (see Pulapura Para. [0093]), while Lecuivre teaches that collagen, when combined with glycerol as a coating, provides surgical mesh devices with anti-adhesive properties (see Lecuivre Para. [0045], [0049] and [0052]).
Regarding claim 21, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 20, Pulapura, as modified by Riley, further discloses wherein the insert is positioned in the second cavity (see Riley Para. [0029]) such that an outer surface of the insert directly engages an inner surface of the pocket, the inner surface defining the second cavity (the protrusions of Riley are modified (see rejection of Claim 20 above), as a matter of obviousness, to be sized and shaped such that the protrusion conforms to the size and shape of the cavity of the surgical mesh of Pulapura to more effectively store and secure the mesh device; since the surgical mesh is a non-rigid device, the protrusion of Riley being of conforming size and shape would allow the surgical mesh to be effectively stored in its intended shape).
Regarding claim 22, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 20, Pulapura, as modified by Riley, further discloses wherein the insert is positioned in the second cavity such that an entire outer surface of the insert directly engages an inner surface of the pocket, the inner surface defining the second cavity (the protrusions of Riley are modified (see rejection of Claim 20 above), as a matter of obviousness, to be sized and shaped such that the protrusions conform to the size and shape of the cavity of the surgical mesh of Pulapura to more effectively store and secure the mesh device due to the direct abutting contact between the two components; since the surgical mesh is a non-rigid device, the protrusion of Riley being of conforming size and shape to be in direct engagement with the internal cavity of the surgical mesh would allow the surgical mesh to be effectively stored in its intended shape).
Regarding claim 23, the combination of Pulapura, Riley disclose the invention of claim 20, Pulapura, as modified by Riley and Lecuivre, further discloses wherein the size and shape of the insert is defined by opposite first and second side walls of the insert that each extend from a top wall of the insert to an opposite bottom wall of the insert (see Riley Figs. 1A-1B showing wherein the protrusions have two pairs of opposing side walls), the top wall being convexly curved from the first side wall to the second side wall (the top wall of the protrusion of Riley has been modified in the rejection of Claim 20 above to be convexly curved as a matter of obviousness per the disclosure of Riley).
Regarding claim 24, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 23, Pulapura, as modified by Riley, further discloses wherein the first side wall extends parallel to the second side wall from the top wall to the bottom wall of the insert (each opposing pair of side walls have been modified to extend parallel to one-another as a matter of obviousness in the rejection of Claim 20 above).
Regarding claim 25, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 24, Pulapura, as modified by Riley, further discloses wherein the insert includes opposite front and back walls that each extend from the top wall to the bottom wall of the insert and from the first side wall to the second side wall (see Riley Figs. 1A-1B showing wherein each protrusion have four side walls extending between a top and bottom wall of the protrusion), the front wall extending parallel to the back wall from the top wall to the bottom wall of the insert (each opposing pair of side walls have been modified to extend parallel to one-another as a matter of obviousness in the rejection of Claim 20 above).
Regarding claim 26, Pulapura discloses:
A surgical system comprising:
a surgical device (see Fig. 6) comprising a substrate (component 22, see Fig. 6), the substrate comprising a first piece (first piece 22a, see Examiner’s Diagram of Fig. 6 below) and a second piece (second piece 22b, see Examiner’s Diagram of Fig. 6 below) that is joined with the first piece (see Fig. 6; see also Para. [0073]), the first piece and the second piece forming a pocket having a second cavity (cavity “C”, see Fig. 6 and Para. [0073]) and a second opening (opening “O”, see Fig. 6 and Para. [0073]) that is in communication with the second cavity (see Fig. 6 and Para. [0073]);
the device comprises a coating that covers at least a portion of the substrate (see Para. [0104]), the coating comprising collagen (see Para. [0093] mentioning wherein the hemostatic coating may comprise collagen), and hemostatic agent (see Para. [0093] mentioning wherein the coating may comprise tranexamic acid (a hemostatic agent) in addition to collagen).
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Examiner’s Diagram of Fig. 6
However, Pulapura does not expressly disclose:
a package comprising:
a body having a side wall extending from a top end to a bottom end, a bottom wall coupled to the bottom end of the side wall, inner surfaces of the side wall and the bottom wall defining a first cavity, the top end of the side wall defining a first opening that is in communication with the first cavity, and
an insert extending from the bottom wall such that the insert is positioned in the first cavity, the insert having a size and shape; and
the device being pre-formed such that a size and shape of the second cavity conforms to the size and shape of the insert;
wherein the insert is configured to be positioned in the second cavity; and
wherein the coating further comprises glycerin.
In the same field of endeavor, namely packing devices for surgical equipment, Riley teaches:
A surgical instrument package (kit tray 1 , see Figs. 1A-1C) comprising:
A body (exterior shell of kit tray 1, see Figs. 1A-1C) including four side walls having top and bottom ends (see Figs. 1A-1C) and opposing top and bottom walls connected to the four side walls (see Figs. 1A-1C; the top/lid is shown in Figs. 2A-2B per Para. [0032]-[0033]; the surgical kit tray also inherently comprises a top wall so as to retain surgical devices therein prior to use) defining a first cavity disposed between and within the four side wall and opposing top and bottom walls (see Figs. 1A-1C); the top ends of the side walls defining a first opening that is in communication with the first cavity (see Figs. 1A-1B showing wherein an opening is defined at the “top” of the kit tray housing which allows access to the inner storage lumen of the container) and a plurality of inserts (protrusions 21, see Figs. 1A-1C) extending from the bottom wall (see Figs. 1A-1B) such that the inserts are positioned in the first cavity (see Figs. 1A-1B), the inserts having a size and shape (see Figs. 1A-1B); and
One or more surgical devices (see Para. [0029] mentioning a plurality of “kit contents” surgical devices configured to be stored within the kit tray packaging) having a pocket defining a second cavity and associated opening therein that is configured to be inserted onto one of the plurality of inserts such that the insert forms a fitted connected within the internal pocket of the surgical device (see Para. [0029] mentioning wherein one of the surgical devices stored within the kit tray packaging may have cavities to allow insertion of the one or more protrusions into the device to form a loose fit with said object) wherein the pocket of the surgical device therefore comprises a shape that is pre-formed to be fitted onto the one or more protrusions (see Para. [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Pulapura to comprise a package container comprising four side walls, a bottom wall and a top wall defining an internal cavity within the package container; the package further comprising at least one protruding insert extending radially upward from the bottom wall into the internal cavity of the package container configured to be inserted within the cavity of the surgical mesh of Pulapura as taught and suggested by Riley to, in this case, provide a sealed storage container for the surgical device of Pulapura prior to use (see Riley Para. [0029]).
While Riley teaches wherein the protrusions can have any desired width, length, height and/or geometric shape to allow the protrusions to be placed inside a desired object to allow for secure storage of the desired items (see Para. [0029]), Riley does not expressly disclose:
wherein the surgical device is pre-formed such that a size and shape of the second cavity conforms to the size and shape of the insert when the surgical device is positioned in the first cavity; and
wherein the insert is configured to maintain the size and shape of the second cavity when the surgical device is positioned in the first cavity and the insert is positioned in the second cavity.
However, since Riley discloses that the protrusions can have and desired width, length, length and/or geometric shape to allow the protrusions to be placed inside a desired object to allow for secure storage of the desired item (see Riley Para. [0029]), it would have been obvious to one of ordinary skill in the art to have modified the protrusions of Riley to be sized and shaped to conform to the second cavity of the surgical mesh of Pulapura such that the protrusion maintains the size and shape of the second cavity when the surgical mesh is positioned in the first cavity and the protrusion is positioned in the second cavity in order to secure the surgical mesh of Pulapura onto the protrusion of the package of Riley.
In the same field of endeavor, namely mesh prosthesis devices designed to limit foreign body reactions when implanted in the body of a patient, Lecuivre teaches an implantable surgical mesh device (see Para. [0007]-[0009)] comprising a coating that is anti-adhesion to avoid post-surgical fibrotic adhesions (see Para. [0045] and [0049]); wherein said coating is comprised of collagen and glycerin (see Para. [0049] and [0052] mentioning wherein glycerin/glycerol may be the glycol of choice).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the coating of Pulapura to be comprised of tranexamic acid (as the hemostatic component), collagen and glycerin as taught and suggested by Lecuivre. The choice would have been obvious because Pulapura teaches both collagen and tranexamic acid as envisioned hemostatic agents can be employed in combination (see Pulapura Para. [0093]), while Lecuivre teaches that collagen, when combined with glycerol as a coating, provides surgical mesh devices with anti-adhesive properties (see Lecuivre Para. [0045], [0049] and [0052]).
Regarding claim 27, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 26, Pulapura, as modified by Riley, further discloses wherein the insert is positioned in the second cavity (see Riley Para. [0029]) such that an outer surface of the insert directly engages an inner surface of the pocket, the inner surface defining the second cavity (per the disclosure of Riley, the protrusion of Riley have been modified, as a matter of obviousness in the rejection of Claim 26 above, the be sized and shaped such that the protrusion conforms to the size and shape of the cavity of the surgical mesh of Pulapura to more effectively store and secure the mesh device; since the surgical mesh is a non-rigid device, the protrusion of Riley being of conforming size and shape would allow the surgical mesh to be effectively stored in its intended shape).
Regarding claim 28, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 26, Pulapura, as modified by Riley, further discloses wherein the insert is positioned in the second cavity such that an entire outer surface of the insert directly engages an inner surface of the pocket, the inner surface defining the second cavity (per the disclosure of Riley, the protrusion of Riley have been modified, as a matter of obviousness in the rejection of Claim 26 above, the be sized and shaped such that the protrusion conforms to the size and shape of the cavity of the surgical mesh of Pulapura to more effectively store and secure the mesh device; since the surgical mesh is a non-rigid device, the protrusion of Riley being of conforming size and shape would allow the surgical mesh to be effectively stored in its intended shape).
Regarding claim 29, the combination of Pulapura, Riley and Lecuivre disclose the invention of claim 26, Pulapura, as modified by Riley, further discloses wherein the size and shape of the insert is defined by opposite first and second side walls of the insert that each extend from a top wall of the insert to an opposite bottom wall of the insert (see Riley Figs. 1A-1B).
However, while Riley discloses wherein the protrusions may comprise any size or geometric shape to accommodate a desired object (see Riley Para. [0029]), the combination, as currently presented, does not expressly disclose wherein the top wall of the insert is convexly curved from the first side wall to the second side wall.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) to have obtained the predictable result of having the top surface of the protrusion of Riley have a convex, rounded shape as suggested to be an obvious modification in changing the shape of a portion of the protrusion(s) by Riley because Riley indicates that the top surface of the protrusions in a surgical equipment storage case configured to be inserted into said surgical equipment may have any size or configuration to store a desired piece of equipment, including a rounded tip as shown in Riley Fig. 2C (see Riley Para. [0029]). The term “may”, pertaining to the varied geometric size/shape of the protrusions of Riley indicates that the size and configuration are not important features and one of ordinary skill in the art would have been able to alter and change the size and configuration of the protrusion of Riley to have a rounded tip to better fit into a pocket of a desired piece of surgical equipment.
Regarding claim 30, the combination of Pulapura, Riley and Lecuivre disclose all of the limitations of the invention of claim 29.
However, while Riley shows wherein the first and second side walls of the protrusions are “substantially parallel” to one-another, Riley does not disclose wherein the first and second side walls are parallel to one-another.
Since Riley teaches wherein the size and shape of the protrusions may be varied to have any size or geometric shape to accommodate a desired surgical object (see Riley Para. [0029]), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) to have obtained the predictable result of having the side walls of the protrusion of Riley to be parallel to each opposing side wall as suggested by Riley because Riley indicates that size and shape of protrusions in a surgical equipment storage case configured to be inserted into said surgical equipment may have any size or configuration to store a desired piece of equipment, seen to include parallel side walls (see Riley Para. [0029]). The term “may”, as pertaining to the varied size and shape of the protrusions of Riley, indicates that the size and shape configuration are not important features and one of ordinary skill in the art would have been able to alter and shape of the protrusion of Riley to have side walls that are parallel to one-another with an expectation that the protrusion would still operate properly unless otherwise stated by Riley.
Regarding claim 31, the combination of Pulapura, Riley and Lecuivre disclose all of the limitations of the invention of claim 30, Pulapura, as modified by Riley, further discloses wherein the insert includes opposite front and back walls that each extend from the top wall to the bottom wall of the insert and from the first side wall to the second side wall (Riley Figs. 1A-1B showing wherein the protrusions have four side walls extending between a top and bottom of the protrusion body), the front wall extending parallel to the back wall from the top wall to the bottom wall of the insert (each opposing side wall of the protrusions of Riley have been modified, as a matter of obviousness, to be parallel to each other per the rejection of Claim 30 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically US 2006/0010840 A1 to Ashiya, US 2007/0023303 A1 to Templeton and US 4697703 A to Will all disclose surgical packing or container devices related to the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771