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 .
Response to Arguments
Applicant's arguments filed 6/8/2026 have been fully considered but they are not persuasive.
Regarding independent claims 10, 26 and 26, Applicant contends that none of either Pulapura (US 2017/0319754 A1) or Riley (US 2006/0011506 A1) expressly disclose or adequately suggest the amended limitations of “wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device to maintain the size and shape of the second cavity of the surgical device to prevent stretching and/or wetting of the surgical device to fit the implantable medical device within the second cavity” on the grounds that, while Riley discloses wherein the one or more protrusions of the surgical instrument package, as incorporated into the device system of Pulapura, may be sized and shaped to be inserted into corresponding cavity of surgical instruments to provide storage therefore (see Riley Para. [0029]), Riley does not provide adequate disclosure of the protrusions being sized and shaped to conform to the size and shape of an implantable medical device to maintain the size and shape of the second cavity”, as currently amended.
In regards to the currently-presented limitations of “wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device to maintain the size and shape of the second cavity”, this limitation is understood to recite wherein the size and shape of the insert is at least substantially similar to the size and shape of the implantable medical device such that the size and shape of the surgical device is maintained during both storage and use (see Specification Para. [0137]). The Examiner therefore contends that the size and shape of the insert does not need to “conform” to the size and shape of the implantable device, but rather merely have a similar size and shape such that, depending on which tool is inserted within the cavity of the surgical device, the surgical device’s size and shape is maintained by the tool inserted therein.
In keeping with this interpretation, Pulapura provides disclosure in Para. [0073]-[0078] of wherein an implantable device may be inserted either entirely within or partially within the cavity of the component 22 (i.e., the surgical device) such that the implantable device is encased within and immobilized by the confines of the component 22. Therefore, one of ordinary skill in the art would understand that the implantable device of Pulapura is sized and shaped to maintain the size and shape of the cavity of the component.
Additionally, 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]), one of ordinary skill in the art would have found it obvious to have modified the protrusions of Riley to be sized and shaped to conform to the peripheral confines of the second cavity of the component 22 of Pulapura such that the protrusion maintains the size and shape of the second cavity when the component 22 is positioned in the first cavity of the package container while the protrusion is positioned in the second cavity in order to secure the component 22 of Pulapura onto the protrusion of the package of Riley (i.e., such that the component does not slide off during transport prior to use).
As both the protrusions of Riley, whose sizes and shapes have been modified to fit within the cavity of the component of Pulapura as a matter of obviousness, and the implantable device disclosed by Pulapura are configured to be sized and shaped so as to maintain the size and shape of the cavity of the component, the Examiner respectfully contends that the amended limitations are reasonably suggested by the prior art.
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 13-17 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).
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; see also Para. [0073] mentioning wherein component 22 is formed from two pieces (22a/22b) joined together) and a second piece (second piece 22b, see Examiner’s Diagram of Fig. 6 below; see also Para. [0073] mentioning wherein component 22 is formed from two pieces (22a/22b) joined together) 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 being pre-formed such that a size and shape of the second cavity confirms to a size and shape of an implantable medical device (see Para. [0073]-[0078] mentioning wherein an implantable device may be disposed within the cavity “C” of component 22 such that it is encased and enclosed within the confines of the component; Para. [0078] further mentions wherein the component 22 may comprise a size/shape that supports and immobilizes the enclosed implantable device disposed therein and is thus seen to conform to the size and shape of the implantable device); and
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]); and
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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 positioned in the first cavity of the package and the insert is positioned in the second cavity of the surgical device, wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device to maintain the size and shape of the second cavity of the surgical device to prevent stretching and/or wetting the surgical device to fit the implantable medical device within 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 (see Figs. 1A-1C showing wherein the kit tray has four peripherical sidewalls defining an interior space) having top and bottom ends (see Figs. 1A-1C showing top and bottom ends of the sidewalls of the kip tray) and opposing top and bottom walls connected to the four side walls (see Figs. 1A-1C and Fig. 2B showing a bottom floor 4 and top lid 100; see also Para. [0032]-[0033]); wherein a first cavity is defined between and radially-within the four side wall and opposing top and bottom walls (see Figs. 1A-1C showing a cavity within which protrusions 21 are disposed; this cavity defining a “first cavity”); 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 which allows access to the inner storage space); and a plurality of inserts (protrusions 21, see Figs. 1A-1C) extending from the bottom wall (see Figs. 1A-1B showing wherein the protrusions 21 extend from the bottom floor 4) 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
a surgical device (see Para. [0029] mentioning a plurality of “kit contents” which may be surgical devices configured to be stored within the kit tray packaging) having a pocket cavity defining a second cavity and associated opening that is configured to be inserted onto one of the plurality of inserts within the first cavity of the instrument package such that the insert forms a fitted connection within the internal second cavity of the surgical device (see Para. [0029] mentioning wherein surgical devices stored within the kit tray packaging may have “second cavities” to allow insertion of the one or more protrusions of the kit tray therein such that the surgical device(s) may be “wrapped around the one or more protrusions, to allow the protrusions to be placed inside the desired surgical device and/or kit content” while optionally forming a loose fit with the surgical device and/or kit content); wherein the disclosed loose fit connection (see Para. [0029]) prevents stretching of the surgical device when placed upon one of the plurality of inserts; the “second cavity” of the surgical device is therefore understood to comprises a shape that is pre-formed to be fitted onto the one or more protrusions without stretching (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 peripheral side walls, a bottom wall and a top wall which together define an internal “first cavity” within the package container; the package further comprising at least one protruding insert extending radially upward from the bottom wall into the “first cavity” of the package container configured to be inserted within the “second cavity” of the component 22 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 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; and
wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device.
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 peripheral confines of the second cavity of the component 22 of Pulapura such that the protrusion maintains the size and shape of the second cavity when the component 22 is positioned in the first cavity of the package container while the protrusion is positioned in the second cavity in order to secure the component 22 of Pulapura onto the protrusion of the package of Riley (i.e., such that the component does not slide off during transport prior to use).
Regarding the limitations of “wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device”, this limitation is interpreted to claim wherein the size/shape of the surgical instrument package insert is substantially the same as the size/shape of the implantable medical device such that the insert of the surgical instrument package maintains the size/shape of the “second cavity” of the surgical device when the surgical device is packaged and inserted onto the insert, and wherein the implantable medical device maintains the size/shape of the “second cavity” when the surgical device is unpackaged (see Specification Para. [0137]). As a result of the dimensional modification, the protrusions of the kit tray of Riley would have a substantially similar size/shape to the implantable medical device as both features are intended to be inserted within and maintain the size/shape of the “second cavity” of the component 22 of Pulapura (see Riley Para. [0029] and Pulapura Para. [0073]-[0078]).
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) (previously of record).
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 being pre-formed such that a size and shape of the second cavity conforms to a size and shape of an implantable medical device (see Para. [0073]-[0078] mentioning wherein an implantable device may be disposed within the cavity “C” of component 22 such that it is encased and enclosed within the confines of the component; Para. [0078] further mentions wherein the component 22 may comprise a size/shape that supports and immobilizes the enclosed implantable device disposed therein and is thus seen to conform to the size and shape of the implantable device);
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;
wherein the surgical device is positioned in the first cavity of the package and the insert is positioned in the second cavity of the surgical device;
wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device to maintain the size and shape of the second cavity of the surgical device to prevent stretching and/or wetting of the surgical device to fit the implantable medical device within the second cavity.
wherein the coating comprises glycerin.
In the same field of endeavor, namely packing devices for surgical equipment, Riley teaches:
A body (exterior shell of kit tray 1, see Figs. 1A-1C) including four side walls (see Figs. 1A-1C showing wherein the kit tray has four peripherical sidewalls defining an interior space) having top and bottom ends (see Figs. 1A-1C showing top and bottom ends of the sidewalls of the kip tray) and opposing top and bottom walls connected to the four side walls (see Figs. 1A-1C and Fig. 2B showing a bottom floor 4 and top lid 100; see also Para. [0032]-[0033]); wherein a first cavity is defined between and radially-within the four side wall and opposing top and bottom walls (see Figs. 1A-1C showing a cavity within which protrusions 21 are disposed; this cavity defining a “first cavity”); 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 which allows access to the inner storage space); and a plurality of inserts (protrusions 21, see Figs. 1A-1C) extending from the bottom wall (see Figs. 1A-1B showing wherein the protrusions 21 extend from the bottom floor 4) 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
a surgical device (see Para. [0029] mentioning a plurality of “kit contents” which may be surgical devices configured to be stored within the kit tray packaging) having a pocket cavity defining a second cavity and associated opening that is configured to be inserted onto one of the plurality of inserts within the first cavity of the instrument package such that the insert forms a fitted connection within the internal second cavity of the surgical device (see Para. [0029] mentioning wherein surgical devices stored within the kit tray packaging may have “second cavities” to allow insertion of the one or more protrusions of the kit tray therein such that the surgical device(s) may be “wrapped around the one or more protrusions, to allow the protrusions to be placed inside the desired surgical device and/or kit content” while optionally forming a loose fit with the surgical device and/or kit content); wherein the disclosed loose fit connection (see Para. [0029]) prevents stretching of the surgical device when placed upon one of the plurality of inserts; the “second cavity” of the surgical device is therefore understood to comprises a shape that is pre-formed to be fitted onto the one or more protrusions without stretching (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 peripheral side walls, a bottom wall and a top wall which together define an internal “first cavity” within the package container; the package further comprising at least one protruding insert extending radially upward from the bottom wall into the “first cavity” of the package container configured to be inserted within the “second cavity” of the component 22 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]). The resulting “loose fit” disclosed by Riley would allow the protrusions of the kit tray to insert into and maintain the size and shape of the “second cavity” of the component 22 of Pulapura without stretching the device.
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; and
wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device to maintain the size and shape of the second cavity of the surgical device to prevent stretching and/or wetting of the surgical device to fit the implantable medical device within 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 peripheral confines of the second cavity of the component 22 of Pulapura such that the protrusion maintains the size and shape of the second cavity when the component 22 is positioned in the first cavity of the package container while the protrusion is positioned in the second cavity in order to secure the component 22 of Pulapura onto the protrusion of the package of Riley (i.e., such that the component does not slide off during transport prior to use).
Regarding the limitations of “wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device”, this limitation is interpreted to claim wherein the size/shape of the surgical instrument package insert is substantially the same as the size/shape of the implantable medical device such that the insert of the surgical instrument package maintains the size/shape of the “second cavity” of the surgical device when the surgical device is packaged and inserted onto the insert, and wherein the implantable medical device maintains the size/shape of the “second cavity” when the surgical device is unpackaged (see Specification Para. [0137]). As a result of the dimensional modification described above, the protrusions of the kit tray of Riley would have a substantially similar size/shape to the implantable medical device as both features are intended to be inserted within and maintain the size/shape of the “second cavity” of the component 22 of Pulapura (see Riley Para. [0029] and Pulapura Para. [0073]-[0078]).
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]);
wherein the device is pre-formed such that a size and shape of the second cavity conforms to a size and shape of an implantable medical device (see Para. [0073]-[0078] mentioning wherein an implantable device may be disposed within the cavity “C” of component 22 such that it is encased and enclosed within the confines of the component; Para. [0078] further mentions wherein the component 22 may comprise a size/shape that supports and immobilizes the enclosed implantable device disposed therein and is thus seen to conform to the size and shape of the implantable device);
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; and
wherein the surgical device is positioned in the first cavity of the package and the insert is positioned in the second cavity of the surgical device;
wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device to maintain the size and shape of the second cavity of the surgical device to prevent stretching and/or wetting the surgical device to fit the implantable medical device within 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 body (exterior shell of kit tray 1, see Figs. 1A-1C) including four side walls (see Figs. 1A-1C showing wherein the kit tray has four peripherical sidewalls defining an interior space) having top and bottom ends (see Figs. 1A-1C showing top and bottom ends of the sidewalls of the kip tray) and opposing top and bottom walls connected to the four side walls (see Figs. 1A-1C and Fig. 2B showing a bottom floor 4 and top lid 100; see also Para. [0032]-[0033]); wherein a first cavity is defined between and radially-within the four side wall and opposing top and bottom walls (see Figs. 1A-1C showing a cavity within which protrusions 21 are disposed; this cavity defining a “first cavity”); 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 which allows access to the inner storage space); and a plurality of inserts (protrusions 21, see Figs. 1A-1C) extending from the bottom wall (see Figs. 1A-1B showing wherein the protrusions 21 extend from the bottom floor 4) 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
a surgical device (see Para. [0029] mentioning a plurality of “kit contents” which may be surgical devices configured to be stored within the kit tray packaging) having a pocket cavity defining a second cavity and associated opening that is configured to be inserted onto one of the plurality of inserts within the first cavity of the instrument package such that the insert forms a fitted connection within the internal second cavity of the surgical device (see Para. [0029] mentioning wherein surgical devices stored within the kit tray packaging may have “second cavities” to allow insertion of the one or more protrusions of the kit tray therein such that the surgical device(s) may be “wrapped around the one or more protrusions, to allow the protrusions to be placed inside the desired surgical device and/or kit content” while optionally forming a loose fit with the surgical device and/or kit content); wherein the disclosed loose fit connection (see Para. [0029]) prevents stretching of the surgical device when placed upon one of the plurality of inserts; the “second cavity” of the surgical device is therefore understood to comprises a shape that is pre-formed to be fitted onto the one or more protrusions without stretching (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 peripheral side walls, a bottom wall and a top wall which together define an internal “first cavity” within the package container; the package further comprising at least one protruding insert extending radially upward from the bottom wall into the “first cavity” of the package container configured to be inserted within the “second cavity” of the component 22 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]). The resulting “loose fit” disclosed by Riley would allow the protrusions of the kit tray to insert into and maintain the size and shape of the “second cavity” of the component 22 of Pulapura without stretching the device.
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 the limitations of “wherein the insert is sized and shaped to conform to the size and shape of the implantable medical device”, this limitation is interpreted to claim wherein the size/shape of the surgical instrument package insert is substantially the same as the size/shape of the implantable medical device such that the insert of the surgical instrument package maintains the size/shape of the “second cavity” of the surgical device when the surgical device is packaged and inserted onto the insert, and wherein the implantable medical device maintains the size/shape of the “second cavity” when the surgical device is unpackaged (see Specification Para. [0137]). As a result of the dimensional modification described above, the protrusions of the kit tray of Riley would have a substantially similar size/shape to the implantable medical device as both features are intended to be inserted within and maintain the size/shape of the “second cavity” of the component 22 of Pulapura (see Riley Para. [0029] and Pulapura Para. [0073]-[0078]).
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 2013/0030360 A1 to Stopek, US 8642831 B2 to Larsen and US 2019/0262510 A1 to Chen all disclose surgical packing or container devices related to the claimed invention.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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