DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-27, 31-34, and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (U.S. Pat. Pub. No. 2015/0230868 A1).
Regarding claim 21, Miller discloses a surgical apparatus, comprising: a flexible pad (assembly of body 112 and hub 148) positionable over an incision (I) at a surgical site for providing a gas seal between a bottom surface (lip 128 of the first body side 116 of the body 112) of the flexible pad and a sealable surface (patient’s skin) of the surgical site that surrounds the incision (see Fig. 1-5 and [0013-0014]), wherein the flexible pad includes an opening (top opening of hub 148, communicating hub cavity 176 and the incision with the outside) therein that provides a portal (slit 184) through which a surgical instrument can be passed to allow access to the surgical site through the opening (see Fig. 2-5 and [0019-0020]), the opening extending between a top surface (second body side 120) of the flexible pad and said bottom surface (see Fig. 2-5, [0014], and [0019-0020]); and a fluid-flow lumen (assembly of passage 188 and flexible tube 200, which may be integral to the passage 188 – see [0025]) providing a fluid pathway through the surgical apparatus to the surgical site (see Fig. 2-5 and [0024-0026]), wherein at least part of the fluid-flow lumen extends laterally across the flexible pad between a peripheral edge (perimeter 124) of the flexible pad and the opening (see Fig. 2-5), wherein the bottom surface of the flexible pad is conformable and extends outward from the opening toward the peripheral edge of the flexible pad (see Fig. 2-5, [0013], ln 17-20, and [0014]).
Regarding claim 22, Miller discloses that the portal comprises a resealable port (flexible member 180 – see [0020]).
Regarding claim 23, Miller disclose that the resealable port includes a septum (flexible member 180 – see [0020]).
Regarding claim 24, Miller discloses that a sealing member (flexible member 180) is positioned in the opening, the portal (slit 184) located in the sealing member (see Fig. 2-5 and [0020]).
Regarding claim 25, Miller disclose that the fluid-flow lumen is fluidly connected to the sealing member (see Fig. 2-5 and [0024-0025], wherein the assembly of passage 188 and flexible tube 200 provide a fluid passage which is fluidly connected to the flexible member 180 via hub cavity 176).
Regarding claim 26, Miller discloses that the fluid-flow lumen extends across the peripheral edge of the flexible pad (see Fig. 2-5, wherein the flexible tube 200 portion extends across the perimeter 124 of body 112).
Regarding claim 27, Miller discloses that a conduit (the fluid passage formed within hollow flexible tube 200 and passage 188) is located at least partially within the fluid-flow lumen (see Fig. 2-5 and [0024-0025]).
Regarding claim 31, Miller discloses that the bottom surface of the flexible pad is sealable against skin of a patient (via lip 128, see Fig. 3 and [0014-0016]).
Regarding claim 32, Miller discloses that an adhesive is provided on the bottom surface of the flexible pad (on lip 128 – see [0015-0016]).
Regarding claim 33, Miller discloses that the flexible pad includes an adhesive-free zone surrounding the opening (see [0015-0016], wherein adhesive is only applied to the lip 128).
Regarding claim 34, Miller discloses that the surgical apparatus may further comprise a surgical instrument (biopsy needle 104) extending through the portal (see Fig. 3, [0013], and [0019-0023]).
Regarding claim 36, Miller discloses that the portal is able to maintain a gas-sealed fit with an outer surface of the surgical instrument when the surgical instrument is extending through the portal ([0020]).
Regarding claim 37, Miller discloses that the fluid-flow lumen is able to flex along with the flexible pad while maintaining said fluid pathway (see Fig. 2-5 and [0025-0026], wherein the flexible tube 200 portion of the fluid-flow lumen is provided as separate from the body 112 and is flexible, thereby it is able to flex at least to a degree while maintaining a fluid pathway when the body 112 also flexes).
Regarding claim 38, Miller discloses that the portal is positioned adjacent a distal end of the fluid-flow lumen (see Fig. 2-5, wherein the distal end at passage 188 is joined to the hub cavity 176, adjacent to the flexible member 180 and slit 184).
Claim Rejections - 35 USC § 103
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) 21-28, 31-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Hart (U.S. Pat. No. 5,848,992) in view of Callas (U.S. Pat. No. 6,811,546).
Regarding claim 21, Hart discloses a surgical apparatus, comprising: a flexible pad (assembly of flexible base 14 and hollow stem 18) positionable over an incision (surgical incision 20) at a surgical site for providing a gas seal between a bottom surface of the flexible pad and a sealable surface (skin 16) of the surgical site that surrounds the incision (see Fig. 1-12 , Col. 3, ln 17-46, and Col. 6, ln 3-30), wherein the flexible pad includes an opening (opening 28 in hollow stem 18) therein that provides a portal through which a surgical instrument (operative instrument 24) can be passed to allow access to the surgical site through the opening (see Fig. 1-3, Col. 6, ln 3-13, and Col. 6, ln 51 – Col. 7, ln 12), the opening extending between a top surface of the flexible pad and said bottom surface (see Fig. 1-3 and Col. 6, ln 3-50), and wherein the bottom surface of the flexible pad is conformable and extends outward from the opening toward the peripheral edge of the flexible pad (see Fig. 1-3 and Col. 6, ln 3-26).
Hart fails to teach that the surgical apparatus comprises a fluid-flow lumen providing a fluid pathway through the surgical apparatus to the surgical site, wherein at least part of the fluid-flow lumen extends laterally across the flexible pad between a peripheral edge of the flexible pad and the opening, however, Hart teaches that the surgical apparatus may be used for surgical procedures that require insufflation of a cavity within the patient (providing positive pressure fluid flow into a cavity of the body to distend the cavity, thereby allowing surgical access – see Hart, Col. 7, ln 3-7, Col. 9, ln 50-54, and Col. 10, ln 4-8), and it is well known within the art that such procedures require that a fluid pathway be provided through any such surgical apparatus structures, whereby pressurized fluid may be introduced to the incision. Such is taught, for example, by Callas, which exhibits a surgical apparatus (surgical access port) similar to that of Hart and teaches that such an apparatus may comprise a fluid-flow lumen (insufflation gas inlet 25) providing a fluid pathway through the surgical apparatus to the surgical site (see Fig. 1-4 and Col. 3, ln 29-36), wherein the fluid-flow lumen extends laterally from a central hub portion (body 9) comprising the opening (opening of central bore 15) towards a peripheral edge of the base (transition section 23) upon which it is provided (see Fig. 1-2, wherein the insufflation gas inlet 25 extends along and across the surface of base/transition section 23 towards the peripheral edge of the base/transition section 23), in order to thereby enable insufflation of the body cavity to be operated upon (Col. 1, ln 36-56, Col. 2, ln 6-12, and Col. 3, ln 29-36). Thus, based on the teachings and example of Callas, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical apparatus of Hart to further comprise a fluid-flow lumen providing a fluid pathway through the surgical apparatus to the surgical site, such as taught by Callas, wherein at least part of the fluid-flow lumen may extends laterally from the hub portion (stem 18) of Hart, and thereby across the flexible pad between a peripheral edge of the flexible pad and the opening (see Fig. 2-3 of Hart) in order to provide a fluid pathway whereby pressurized fluid may be introduced to the incision, thereby enabling insufflation of the body cavity to be operated upon, as described by Callas (Col. 1, ln 36-56, Col. 2, ln 6-12, and Col. 3, ln 29-36), and as is required in some surgical operations (such as vein harvesting within the abdominal cavity – see Callas, Col. 1, ln 36-56, and Hart, Col. 9, ln 38 – 54).
Regarding claim 22, Hart further discloses that the portal comprises a resealable port (instrument seal 30 and operative valve 38 – see Col. 6, ln 51 – Col. 7, ln 12).
Regarding claim 23, Hart further discloses that the resealable port includes a septum (instrument seal 30) and a one-way valve (operative valve 38) (see Col. 6, ln 51 – Col. 7, ln 12).
Regarding claim 24, Hart further discloses that a sealing member (operative valve 38) is positioned in the opening, the portal located in the sealing member (see Fig. 2-3 and Col. 6, ln 51 – Col. 7, ln 12).
Regarding claim 25, Callas further teaches that the fluid-flow lumen (insufflation gas inlet 25) may be fluidly connected to the inner cavity (central bore 15) of the hub (body 9) (see Fig. 1-4 and Col. 3, ln 29-36). It follows that, in the above modification in re claim 21, the fluid-flow lumen provided to the surgical apparatus of Hart would also necessarily be fluidly connected to the inner cavity of the hub (hollow stem 18) of Hart in order to allow insufflation of the incision, and would thereby also be fluidly connected to the sealing member (operative valve 38) (see Fig. 2-3).
Regarding claim 26, Callas further teaches that the fluid-flow lumen (interpreted in regards this claim as also comprising conduit 19) may extend across the peripheral edge of the base (base/transition section 23) upon which it is provided (see Fig. 1-4). Since a fluid-flow lumen of the type taught by Callas is provided within Hart in the above modification (see in re claim 21), it follows that it would further have been obvious, based on these teachings, to implement the fluid-flow lumen of Hart as extending across the peripheral edge of the flexible pad.
Regarding claim 27, Callas further teaches that a conduit (conduit 19) located partially within the fluid-flow lumen (see Fig. 1-4 and Col. 3, ln 29-36) in order to thereby enable insufflation of the body cavity to be operated upon (Col. 1, ln 36-56, Col. 2, ln 6-12, and Col. 3, ln 29-36). Since a fluid-flow lumen of the type taught by Callas is provided within Hart in the above modification (see in re claim 21), it follows that it would further have been obvious, based on these teachings, to implement the fluid-flow lumen of Hart as comprising a conduit that is located at least partially within the fluid-flow lumen, in a similar manner to that of Callas.
Regarding claim 28, Callas further teaches that at least a portion of the conduit may extend out of the fluid-flow lumen in order to thereby fluidly connect to an insufflation fluid source (see Fig. 1-4 and Col. 1, ln 36-56, Col. 2, ln 6-12, and Col. 3, ln 29-36, wherein conduit 19 extends beyond the outward-facing end of insufflation gas inlet 25 in order to allow connection of an insufflation gas source). Since a fluid-flow lumen of the type taught by Callas is provided within Hart in the above modification (see in re claim 21), it follows that it would further have been obvious, based on these teachings, to implement the fluid-flow lumen of Hart such that a portion of the conduit may extend out of the fluid-flow lumen in the manner of Callas in order to thereby fluidly connect to an insufflation fluid source.
Regarding claim 31, Hart discloses that the bottom surface of the flexible pad is sealable against skin of a patient (Col. 7, ln 29-32).
Regarding claim 32, Hart discloses that an adhesive is provided on the bottom surface of the flexible pad (Col. 7, ln 29-32).
Regarding claim 33, Hart discloses that the flexible pad includes an adhesive-free zone surrounding the opening (see Fig. 2-3 and Col. 7, ln 29-32, wherein adhesive is only applied to the bottom surface - flexible base 14 - and not to the hollow stem 18 portion of the pad, which surrounds the opening).
Regarding claim 34, Hart discloses that the surgical apparatus may further comprise a surgical instrument (operative instrument 24) extending through the portal (see Fig. 3 and Col. 6, ln 3-13).
Regarding claim 35, Hart teaches that the surgical apparatus may be used to facilitate endoscopic vein (vessel) harvesting operations (see implementations of Fig. 7-10 and Col. 8, ln 35-40), therefore, it is clear that the surgical instrument may comprise an endoscopic vessel harvester (24b). Further, Callas also teaches that endoscopic vein (vessel) harvesting operations may be performed through small incisions and with the aid of a surgical apparatus (access ports) of the type taught by Hart (Col. 1, ln 22-56 and Col. 2, ln 1-12).
Regarding claim 36, Hart discloses that the portal is able to maintain a gas-sealed fit with an outer surface of the surgical instrument when the surgical instrument is extending through the portal (Col. 6, ln 51-58).
Regarding claim 38, Callas further teaches that the distal end of the fluid-flow lumen may be positioned adjacent to the portal of the surgical apparatus (see Fig. 1-4 and Col. 3, ln 29-36, wherein the insufflation gas inlet 25 comprises an outlet end which outlets into the central bore 15, adjacent to the portal portion through which surgical instruments may be inserted). Since a fluid-flow lumen of the type taught by Callas is provided within Hart in the above modification (see in re claim 21), it follows that it would further have been obvious, based on these teachings, to implement the fluid-flow lumen of Hart such that the distal end of the fluid-flow lumen may be positioned adjacent to the portal of the surgical apparatus, in similar manner to the configuration of Callas.
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hart as modified by Callas according to claim 27 and in further view of Craft (U.S. Pat. Pub. No. 2011/0301419 A1).
Regarding claim 29, Hart as modified by Callas according to claim 27 exhibits the surgical apparatus of claim 27. While Hart fails to teach that a first end of the conduit is insertable into the incision, such is well known within the art for insufflation conduits. For example, Craft exhibits a surgical apparatus (access portal 600) similar to that of Hart (see Fig. 7, [0005-0008] and [0058-0063]) , and teaches that an insufflation conduit (618) may be provided as part of the surgical apparatus, the conduit extending such that it is insertable into the surgical incision in order to thereby enable the insufflation of the specific cavity to be operated upon (see Fig. 7 and [0062]). Based on the teachings and example of Craft, and since the surgical apparatus of Hart is provided with a fluid-flow lumen and conduit to enable insufflation of the patient (see above modification in re claim 21), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the surgical apparatus of Hart such that the insufflation conduit may extend beyond the end of the fluid-flow lumen within the surgical apparatus, such that a first end of the conduit is insertable into the incision, in order to thereby enable the insufflation of the cavity to be operated upon, as described by Craft ([0062]).
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Miller and Galbierz (U.S. Pat. Pub. No. 2019/0110659 A1).
Regarding claim 30, Miller discloses the surgical apparatus of claim 21, wherein the flexible pad is circular (see Fig. 2, 4, and 5, and [0014], ln 12-15). Miller further teaches that the pad must be sized (diameter selected) based upon the expected size of the surgical incision ([0013], ln 9-11 and [0014], ln 16-19). While Miller presents one embodiment in which the diameter of the flexible pad may be between 4 and 5 cm, Miller does not preclude other sizes which may correspond to larger or smaller incisions. Indeed, it is well known within the art that some surgical operations may require larger incisions. Galbierz, for example, exhibits an adhesive flexible pad (adhesive therapeutic cover/bandage 10) similar to the flexible pad of Miller (see Fig. 1-5B and [0038-0042]), and teaches that such a pad may be circular in shape and may be reasonably sized to have a diameter within a range of fractions of an inch to as large as desired ([0040], ln 9-15). Galbierz further exhibits an example in which such a flexible pad may be dimensioned as a 4 inch by 4 inch square ([0046], ln 11-15). Thus, while Miller fails to explicitly teach that the diameter may be within the range of 3-5 inches, it follows from this teaching and from the example of Galbierz that one of ordinary skill in the art would have found it obvious to size the surgical apparatus of Miller by selecting a diameter within the range of 3-5 inches as a matter of routine design selection in order to thereby accommodate an incision of corresponding size (such as less than approximately 3-5 inches), as may be expected to occur is some surgical operations (see the example of Galbierz, wherein a flexible pad of 4 inch length is considered so conventional as to be used as an example size).
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over Hart as modified by Callas according to claim 21 and in further view of Wortrich (U.S. Pat. No. 5,263,939).
Regarding claim 39, Hart as modified by Callas exhibits the surgical apparatus of claim 21. While Hart fails to teach that the flexible pad includes a tab extending outward from the peripheral edge of the flexible pad to provide a grabbable element for facilitating removal of the flexible pad from the surgical site, such a feature is conventional for removable adhesive pads of the type taught by Hart. For example, Wortrich exhibits a surgical apparatus (removable adhesive cannula retaining device 10) similar to that of Hart, comprising a removable adhesive pad (base 20) similar to that of Hart (see Fig. 1-3 and Col. 4, ln 13-40). Wortrich teaches that such a pad may comprise a tab (22) extending outward from the peripheral edge of the flexible pad in order to provide a grabbable element for facilitating removal of the flexible pad from the surgical site (see Fig. 2 and Col. 4, ln 25-30). Thus, based at least upon the teachings of Wortrich, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pad of the surgical apparatus of Hart to include a tab extending outward from the peripheral edge of the flexible pad in order to provide a grabbable element for facilitating removal of the flexible pad from the surgical site, as described by Wortrich (see Fig. 2 and Col. 4, ln 25-30), thereby improving the user’s ability and efficiency at handling the surgical apparatus.
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Miller and Wortrich.
Regarding claim 39, Miller discloses the surgical apparatus of claim 21. While Miller fails to teach that the flexible pad includes a tab extending outward from the peripheral edge of the flexible pad to provide a grabbable element for facilitating removal of the flexible pad from the surgical site, such a feature is conventional for removable adhesive pads of the type taught by Miller. For example, Wortrich exhibits a surgical apparatus (removable adhesive cannula retaining device 10) similar to that of Hart, comprising a removable adhesive pad (base 20) similar to that of Miller (see Fig. 1-3 and Col. 4, ln 13-40). Wortrich teaches that such a pad may comprise a tab (22) extending outward from the peripheral edge of the flexible pad in order to provide a grabbable element for facilitating removal of the flexible pad from the surgical site (see Fig. 2 and Col. 4, ln 25-30). Thus, based at least upon the teachings of Wortrich, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pad of the surgical apparatus of Miller to include a tab extending outward from the peripheral edge of the flexible pad in order to provide a grabbable element for facilitating removal of the flexible pad from the surgical site, as described by Wortrich (see Fig. 2 and Col. 4, ln 25-30), thereby improving the user’s ability and efficiency at handling the surgical apparatus.
Claim(s) 40 is rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Miller, Wortrich, and Wiltshire (WIPO Pub. No. 2012/013986 A1).
Regarding claim 40, Miller does not teach that the fluid-flow lumen extends along a tab. Miller may be modified based upon the teachings of Wortrich to include at least one tab also extending outward from the peripheral edge of the flexible pad (see in re claim 39). Further, it is well known within the art that such features (the fluid-flow lumen and tab) may be combined into one integral assembly – i.e. such that the fluid-flow lumen extends along the tab. For example, Wiltshire exhibits a surgical apparatus (removable flexible adhesive wound management device 10) similar to that of Miller (see Fig. 1 and pg. 4, ln 21 – pg. 6, ln 31), and teaches that such may comprise a flexible pad (assembly of flexible sheets 12 and 14), a fluid-flow lumen (passages 42 and 44, assembled with flexible tubes 62 and 64) providing a conduit through the surgical apparatus and into fluid communication with the surgical site, and a tab portion (neck portion 30) of the flexible pad, wherein the fluid-flow lumen extends along the tab (see Fig. 1-3 and pg. 5, ln 27 – pg. 6, ln 31). Thus, based at least upon the example of Wiltshire and Wortrich, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical apparatus of Miller to include a tab extending outward from the peripheral edge of the flexible pad, in order to thereby provide a grabbable element for facilitating removal of the flexible pad from the surgical site, as described by Wortrich (see in re claim 39), and it would further have been obvious to configure the tab and fluid-flow lumen such that the fluid-flow lumen extends along the tab, as exemplified by Wiltshire, as a routine design choice to integrate these two components as is conventionally done within the art, providing expected advantages such as providing a more integral and flat-profile device (thereby reducing risks of entanglement and unintentional pulling upon the surgical apparatus that may compromise its adherence or seal). See MPEP 2144(V)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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