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 with respect to claim(s) 1 and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Gage (US 2020/0197205 A1) is no longer relied upon to disclose the claimed “everter device” or any components thereof as present in the claims.
Claim Rejections - 35 USC § 102
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 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) 1-2, 4 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohdaira (US 2011/0095067 A1).
Regarding claim 1, Ohdaira discloses:
An everter device (device 1, see Fig. 2) comprising:
a handle configured to be gripped by a user having a first end, a second end, and a gripping member (see Examiner’s Diagram of Fig. 1 below designating a “first end”, “second end” and “gripping member” of an identified “handle” portion), wherein the gripping member includes a plurality of projections (see Examiner’s Diagram of Fig. 1 below showing wherein the gripping member portion comprises a plurality of projecting surfaces formed by the extruded operating unit 140 and an overlapping distal handle segment that has a radially projecting surface relative to the portion of the handle upon which operating unit 140 is located); and
at least one eversion tip (anvil assembly 3, see Fig. 2; the anvil assembly tip is understood to be reasonably capable of performing tissue eversion since it comprises all of the structural limitations present in claim 1 required to perform the recited everting function) rotatably coupled to the handle (see Para. [0332] mentioning wherein the anvil shaft 34 is configured to rotate about the longitudinal axis relative to the stationary handle; see also Fig. 4);
wherein each of the at least one eversion tip is coupled to a respective end of the handle (see Figs. 5 and 29-30), the at least one eversion tip having a distal end, a proximal end, and an eversion surface (see Examiner’s Diagram of Fig. 4 below showing wherein the anvil assembly comprises a “distal end”, a “proximal end” and an “eversion surface” formed as the outer surface of the anvil assembly);
wherein the eversion surface is a curved surface extending between the distal end and the proximal end of the eversion tip (see Fig. 4) wherein the eversion surface transitions from a concave surface at the distal end to a convex surface at a shoulder (see Examiner’s Diagram of Fig. 4 below showing wherein the anvil assembly comprises a concave surface at the distal end thereof and a convex shoulder located proximally thereto);
wherein the shoulder is located at a distance from the proximal end and at a distance from the distal end (see Examiner’s Diagram of Fig. 4 below), and wherein a diameter of the eversion tip at the proximal end is greater than the diameter of the eversion tip at the shoulder (see Examiner’s Diagram of Fig. 4 below showing wherein the proximal-most region of the everting tip (i.e., located at element “31b”) comprises a diameter that is larger than the diameter of the anvil assembly at the shoulder portion).
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Examiner’s Diagram of Fig. 1
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Examiner’s Diagram of Fig. 4
Regarding claim 2, Ohdaira discloses the invention of claim 1, Ohdaira further discloses wherein the at least one eversion tip is removably coupled to the handle (see Para. [0257] and [0273] mentioning wherein the anvil assembly may be separated from the head assembly of the “handle” portion of the device; see also Fig. 1).
Regarding claim 4, Ohdaira discloses the invention of claim 1, Ohdaira further discloses:
wherein the eversion surface includes:
a piloting region starting at the distal end of the eversion tip (see Examiner’s Diagram of Fig. 4_Regions below illustrating a “piloting region” at the distal end of the anvil assembly);
a concave region (see Examiner’s Diagram of Fig. 4_Regions below illustrating a “concave region” along the anvil assembly);
a transition region (see Examiner’s Diagram of Fig. 4_Regions below illustrating a “transition region” along the anvil assembly); and
a nearly linear region ending at the proximal end of the eversion tip (see Examiner’s Diagram of Fig. 4_Regions below illustrating a “nearly linear region” at the proximal end of the anvil assembly in which the proximal region extends substantially linearly except for the proximal-most tip which protrudes radially outward, making the entirety of the proximal region “nearly linear”);
wherein the concave region connects the piloting region to the transition region (see Examiner’s Diagram of Fig. 4_Regions below illustrating wherein the concave region is positioned between the piloting region and transition region), the transition region connects the concave region to the nearly linear region (see Examiner’s Diagram of Fig. 4_Regions below illustrating wherein the transition region is disposed between and connects the concave region to the nearly linear proximal region);
the eversion surface transitions from the concave surface to the convex surface in the transition region (see Examiner’s Diagram of Fig. 4_Regions below showing wherein the anvil assembly transitions from the concave region to the convex shoulder portion) the diameter of the eversion tip in the concave region increases exponentially as the eversion surface approaches the transition region (see Examiner’s Diagram of Fig. 4_Regions below);
the diameter of the eversion tip in the transition region continuously increases through the transition region towards the nearly linear region (see Examiner’s Diagram of Fig. 4_Regions below);
the rate of change of the diameter of the eversion tip in the transition region continuously decreases through the transition region towards the nearly linear region (see Examiner’s Diagram of Fig. 4_Regions below showing wherein the rate of change of the diameter of the anvil assembly decreases along the transition from the concave region to the nearly linear region); and
the diameter of the eversion tip in the nearly linear region continues to increase until reaching the proximal end of the eversion tip (see Examiner’s Diagram of Fig. 4_Regions below showing wherein the diameter of the anvil assembly is continuously increasing until the proximal-most portion of the anvil assembly, labeled as “31b” in Fig. 4).
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Examiner’s Diagram of Fig. 4_Regions
Regarding claim 14, Ohdaira discloses the invention of claim 1, Ohdaira further discloses wherein the handle includes at least one retention barb configured and arranged to retain the at least one eversion tip on the handle (push tube 7, see Fig. 7 and Para. [0301] mentioning wherein the anvil shaft 34 inserts into and couples to push tube 7 of the handle portion of the device).
Regarding claim 15, Ohdaira discloses the invention of claim 14, Ohdaira further discloses wherein the retention barb includes a shelf, a trunk and a cap (see Examiner’s Diagram of Fig. 7 below illustrating a “shelf” (i.e., the radially-outwardly extending proximal portion of locking portion 54), “trunk” (elongate central region of the locking portion 54) and “cap” (distal-most face of the locking portion 54) portions of the push tube), wherein the trunk is adjacent to the shelf and extends from the shelf to the cap (see Examiner’s Diagram of Fig. 7 below showing where the trunk is adjacent the shelf and extends between the cap and shelf portions), the cap configured to resist longitudinal displacement of the eversion tip, and wherein the cap forms a respective end of the handle (see Para. [0301] mentioning wherein the anvil shaft inserts into the push tube; the push tube is understood to resist longitudinal displacement of the eversion tip once secured together).
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Examiner’s Diagram of Fig. 7
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) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable Ohdaira (US 2011/0095067 A1) in view of Pinjala (US 2016/0256159 A1).
Regarding claim 5, Ohdaira discloses all of the limitations of the invention of claim 4.
However, Ohdaira does not expressly disclose wherein the eversion surface is configured to expand radially outward at the shoulder in response to a compressive force applied on the curved surface, wherein the compressive force is applied toward the proximal end.
In the field of endeavor of tissue-contacting head devices, Pinjala teaches a surgical stapling device (see Fig. 1) comprising an anvil head assembly (anvil assembly 112, see Figs. 1-3) including an external anvil cover (anvil cover 180); wherein the anvil assembly, and components thereof, may be fabricated from silicone (see Para. [0038]).
Since Ohdaira does not expressly disclose a material used to form the external face of the anvil assembly, 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 external face of the anvil assembly of Ohdaira to be formed from silicone as disclosed to be a known material used to form anvil assemblies for surgical stapling devices by Pinjala since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)). The expandable nature of the eversion surface of the claimed invention is understood to be a feature/function of the material used to form said eversion surface. As the specification mentions wherein the eversion surface is formed from silicone (see Para. [0015] and [0103]), the silicone used to form the external surface of the anvil assembly of Ohdaira, as modified by the teachings of Pinjala, is understood to be reasonably capable of deforming at the shoulder upon a compressive force applied at the distal end of the anvil assembly.
Regarding claim 6, Ohdaira discloses all of the limitations of the invention of claim 1.
However, Ohdaira does not expressly disclose wherein the eversion tip is made from an elastic material, which is pierceable, deformable, or that is adapted to axially recede to accommodate posts or pins of a coupler ring of an anastomosis clamp system.
In the field of endeavor of tissue-contacting head devices, Pinjala teaches a surgical stapling device (see Fig. 1) comprising an anvil head assembly (anvil assembly 112, see Figs. 1-3) including an external anvil cover (anvil cover 180); wherein the anvil assembly, and components thereof, may be fabricated from silicone (see Para. [0038]).
Since Ohdaira does not expressly disclose a material used to form the external face of the anvil assembly, 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 external face of the anvil assembly of Ohdaira to be formed from silicone as disclosed to be a known material used to form anvil assemblies for surgical stapling devices by Pinjala since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 7, the combination of Ohdaira and Pinjala disclose the invention of claim 6, Ohdaira, as modified by Pinjala, further discloses wherein the elastic material is configured to deform or axially recede when the everter device is advanced into contact with posts or pins of a coupler ring (silicone is an elastic, deformable material and is fully capable of axially receding or deforming when the anvil assembly of Ohdaira comes into contact with posts or pins of a coupler ring).
Regarding claim 8, the combination of the combination of Ohdaira and Pinjala disclose the invention of claim 6, Ohdaira, as modified by Pinjala, further discloses wherein the elastic material is a thermoplastic elastomer (see Para. [0015] of the claimed specification mentioning wherein silicone is classified by Applicant as a thermoplastic elastomer).
Regarding claim 9, the combination of the combination of Ohdaira and Pinjala disclose the invention of claim 8, Ohdaira, as modified by Pinjala, further discloses wherein the thermoplastic elastomer is a silicone elastomer (silicone material of Pinjala, as incorporated into the anvil assembly of Ohdaira).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable Ohdaira (US 2011/0095067 A1) in view of Pinjala (US 2016/0256159 A1), further in view of Plott (US 2018/0271529 A1) (previously of record).
Regarding claim 11, Ohdaira discloses all of the limitations of the invention of claim 1.
However, Ohdaira does not expressly disclose wherein the eversion tip has a Shore A hardness between 10 and 50.
In the field of endeavor of tissue-contacting head devices, Pinjala teaches a surgical stapling device (see Fig. 1) comprising an anvil head assembly (anvil assembly 112, see Figs. 1-3) including an external anvil cover (anvil cover 180); wherein the anvil assembly, and components thereof, may be fabricated from silicone (see Para. [0038]).
Since Ohdaira does not expressly disclose a material used to form the external face of the anvil assembly, 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 external face of the anvil assembly of Ohdaira to be formed from silicone as disclosed to be a known material used to form anvil assemblies for surgical stapling devices by Pinjala since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
In the same field of endeavor, namely surgical devices utilizing medical grade silicone, Plott teaches wherein medical grade silicone comprises a Shore A hardness of between 10 and 50 (see Para. [0012] and [0069]).
Since Pinjala does not expressly disclose a Shore A hardness of the silicone used in the formation of the surgical stapler anvil, it would have been obvious to one of ordinary skill in the art to have looked to the prior art for a known Shore A hardness for medical grade silicone used to form surgical devices. It would have therefore been obvious to one of ordinary skill in the art to have modified the silicone used to form the anvil assembly of Ohdaira to comprise a Shore A hardness of between 10 and 50 as disclosed by Plott to be a known Shore A hardness for medical grade silicone.
Claim(s) 22, 29 and 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable Ohdaira (US 2011/0095067 A1) in view of Sandstrom (US 2008/0249546 A1) (previously of record), further in view of Scifert (US 2007/0265632 A1) (previously of record).
Regarding claim 22, Ohdaira discloses:
An eversion kit comprising:
an everter device (device 1, see Fig. 2) including:
a first handle configured to be gripped by a user having a first end, a second end, and a gripping member (see Examiner’s Diagram of Fig. 1 below designating a “first end”, “second end” and “gripping member” of an identified “handle” portion), wherein the gripping member includes a plurality of projections (see Examiner’s Diagram of Fig. 1 below showing wherein the gripping member portion comprises a plurality of projecting surfaces formed by the extruded operating unit 140 and an overlapping distal handle segment that has a radially projecting surface relative to the portion of the handle upon which operating unit 140 is located); and
at least one eversion tip (anvil assembly 3, see Fig. 2; the anvil assembly tip is understood to be reasonably capable of performing tissue eversion since it comprises all of the structural limitations present in claim 1 required to perform the recited everting function) rotatably coupled to the handle (see Para. [0332] mentioning wherein the anvil shaft 34 is configured to rotate about the longitudinal axis relative to the stationary handle; see also Fig. 4);
wherein each of the at least one eversion tip is coupled to a respective end of the handle (see Figs. 5 and 29-30);
wherein the at least one eversion tip having a distal end, a proximal end, and an eversion surface (see Examiner’s Diagram of Fig. 4 below showing wherein the anvil assembly comprises a “distal end”, a “proximal end” and an “eversion surface” formed as the outer surface of the anvil assembly);
wherein the eversion surface is a curved surface extending between the distal end and the proximal end of the eversion tip (see Fig. 4) wherein the eversion surface transitions from a concave surface at the distal end to a convex surface at a shoulder (see Examiner’s Diagram of Fig. 4 below showing wherein the anvil assembly comprises a concave surface at the distal end thereof and a convex shoulder located proximally thereto);
wherein the shoulder is located at a distance from the proximal end and at a distance from the distal end (see Examiner’s Diagram of Fig. 4 below), and wherein a diameter of the eversion tip at the proximal end is greater than the diameter of the eversion tip at the shoulder (see Examiner’s Diagram of Fig. 4 below showing wherein the proximal-most region of the everting tip (i.e., located at element “31b”) comprises a diameter that is larger than the diameter of the anvil assembly at the shoulder portion).
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Examiner’s Diagram of Fig. 1
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Examiner’s Diagram of Fig. 4
However, Ohdaira does not expressly disclose:
a sizing device including:
a second handle configured to be gripped by the user having a first end portion and a second end portion; and
at least one sizing guide, wherein the at least one sizing guide is coupled to a respective end portion of the handle, the at least one sizing guide having a plurality of sizing apertures and associated sizing indicators that indicate a diameter of the respective at least one sizing guide.
In the same field of endeavor, namely surgical devices configured to contact tissue and configured to be used with a sizing device, Sandstrom teaches:
A sizing device (sizing device 980, see Fig. 43) comprising:
At least one sizing guide (sizing guide apertures A-D as shown in Fig. 43), the at least one sizing guide having a plurality of sizing apertures (apertures A-D, see Fig. 43, see also Para. [0215]) and associated sizing indicators that indicate a diameter of the respective at least one sizing guide (indicator elements A-D that determine which size aperture an element may fit into, see Fig. 43, see also Para. [0215]).
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 “kit” of Ohdaira to include a sizing device as taught and disclosed by Sandstrom to allow a user to measure a desired surgical area and determine a relevant surgical tool to be used that fits the size requirements of said area (see Sandstrom Para. [0215]).
However, Sandstrom does not expressly disclose a handle configured to be gripped by a user having a first end and a second end, wherein the sizing guide is coupled to one end of said handle.
However, in the same field of endeavor, namely surgical measuring devices, Scifert teaches a sizing device (bone cutting template 1106, see Figs. 11-12 and 16, see also Para. [0091]-[0093] mentioning wherein bone cutting template comprises length measurements along a length thereof) and a handle (handle 1400, see Fig. 16) configured to be gripped by a user (see Para. [0096] mentioning wherein 1400 is designated as a handle which would allow a user to grip said element) having a first end (located at element 1408 as shown in Fig. 14) and a second end (located at element 1410 as shown in Fig. 14), wherein the handle is able to be inserted into different bone templates and rotated to be locked in place, see Para. [0096]-[0097]).
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 sizing device of Sandstrom, as incorporated into the “kit” of Ohdaira, to include a handle that can be removably coupled to the sizing device as disclosed by Scifert to, in this case, allow for a more ergonomic handle for a user to use and manipulate the sizing device.
Regarding claim 29, the combination of Ohdaira, Sandstrom and Scifert disclose the invention of claim 22, Ohdaira further discloses wherein the first handle includes at least one retention barb configured and arranged to retain the at least one eversion tip on the first handle (push tube 7, see Fig. 7 and Para. [0301] mentioning wherein the anvil shaft 34 inserts into and couples to push tube 7 of the handle portion of the device).
Regarding claim 31, the combination of Ohdaira, Sandstrom and Scifert disclose the invention of claim 22, Ohdaira, as modified by Sandstrom, further discloses wherein the at least one sizing guide is configured to receive a vessel (see Sandstrom Para. [0215]), and wherein the plurality of sizing apertures are based on different vessel diameters (see Sandstrom Para. [0215] and Fig. 43).
Regarding claim 32, the combination of Ohdaira, Sandstrom and Scifert disclose the invention of claim 22, Ohdaira, as modified by Sandstrom and Scifert, further discloses wherein the second handle includes at least one retention member configured and arranged to retain the at least one sizing guide on the second handle at an angled orientation such that the sizing guide is angled upwards from a bottom of the handle at an angle (see Scifert Para. [0097] mentioning wherein the handle, as incorporated into the sizing device of Sandstrom, comprises a tip that mates with a corresponding aperture on the bone template (sizing device) which is then rotated to be locked in place, noting that the “wings” of the tip comprise “retention barbs” that mates with opening (1122, see Fig. 12) and lock in place when the handle Is inserted and rotated within said opening. Additionally, as the handle of Scifert would connect to the sizing device of Sandstrom in the manner shown in Scifert Fig. 16, the sizing device would be oriented at an angle perpendicular (i.e., at an upward angle of 90 degrees) relative to the handle itself.
Regarding claim 33, the combination of Ohdaira, Sandstrom and Scifert disclose all of the limitations of the invention of claim 22.
However, none of either Ohdaira, Sandstrom or Scifert expressly disclose wherein the plurality of sizing apertures are circular through-holes and have diameters between 0.1mm and 10mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the apertures of the sizing device of Sandstrom et al. to have diameters of between 0.1mm and 10mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Sandstrom et al. would not operate differently with the claimed diameters and since the different apertures (A-D) are intended to have differing diameters for selection of a desired surgical instrument that are not expressly stated and may change depending on the intended area of use by a user. Given the main area of use be within the vasculature (see Para. [0007] and [0087]), which is akin to the disclosed device (see Specification Para. [0005]), the sizing requirement between the two devices are seen to be correlated and therefore, as a result of Sandstrom remaining silent on the disclosed diameters, so long as the diameters (A-D) remain different, the sizing device of Sandstrom would function appropriately in vascular grafting procedures. Further, applicant places no criticality on the range claimed, indicating simply that the apertures have diameters between 0.1 and 10mm see Specification Para. [0038]) without providing any express benefit or intended function of said range.
However, Sandstrom does not expressly disclose wherein the apertures (A-D, see Fig. 43) are in the shape of circular through-holes.
It appears that the sizing device of Sandstrom would operate equally well with the claimed circular shape since the apertures would retain their ability to measure a graft “T” outside the body by inserting said graft into one of the plurality of apertures to accomplish the task of measuring the diameters thereof. Further, applicant does not disclose that the claimed “circular shape” solves any stated problem or is for any particular purpose, with the specification lacking a written description of any recitation or benefit as to the “circular” through-holes. Further, changes in shape are seen to be a matter of choice obvious to a person of ordinary skill in the art absent persuasive evidence that the particular shape is significant (see MPEP 2144.04 (IV)(B), see also in re Dalley, 347 F.2d 669, 149 USPQ 47 (COPA 1956)). Therefore, 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 shapes of the apertures of Sandstrom to be circular through-holes as an obvious matter of design choice within the skill of the art.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable Ohdaira (US 2011/0095067 A1) in view of Sandstrom (US 2008/0249546 A1) (previously of record), further in view of Scifert (US 2007/0265632 A1) (previously of record), further in view of Pinjala (US 2016/0256159 A1).
Regarding claim 25, the combination of Ohdaira, Sandstrom and Scifert discloses all of the limitations of the invention of claim 22.
However, Ohdaira does not expressly disclose wherein the eversion tip is made from an elastic material, which is pierceable, deformable, or that is adapted to axially recede to accommodate posts or pins of a coupler ring of an anastomosis clamp system.
In the field of endeavor of tissue-contacting head devices, Pinjala teaches a surgical stapling device (see Fig. 1) comprising an anvil head assembly (anvil assembly 112, see Figs. 1-3) including an external anvil cover (anvil cover 180); wherein the anvil assembly, and components thereof, may be fabricated from silicone (see Para. [0038]).
Since Ohdaira does not expressly disclose a material used to form the anvil assembly, 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 anvil assembly of Ohdaira to be formed from silicone as disclosed to be a known material used to form anvil assemblies for surgical stapling devices by Pinjala since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable Ohdaira (US 2011/0095067 A1) in view of Sandstrom (US 2008/0249546 A1) (previously of record), further in view of Scifert (US 2007/0265632 A1) (previously of record), further in view of Pinjala (US 2016/0256159 A1), further in view Plott (US 2018/0271529 A1) (previously of record).
Regarding claim 26, the combination of Ohdaira, Sandstrom, and Scifert discloses all of the limitations of the invention of claim 22.
However, none of the combination expressly discloses wherein the eversion tip has a Shore A hardness between 10 and 50.
In the field of endeavor of tissue-contacting head devices, Pinjala teaches a surgical stapling device (see Fig. 1) comprising an anvil head assembly (anvil assembly 112, see Figs. 1-3) including an external anvil cover (anvil cover 180); wherein the anvil assembly, and components thereof, may be fabricated from silicone (see Para. [0038]).
Since Ohdaira does not expressly disclose a material used to form the anvil assembly, 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 anvil assembly of Ohdaira to be formed from silicone as disclosed to be a known material used to form anvil assemblies for surgical stapling devices by Pinjala since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
In the same field of endeavor, namely surgical devices utilizing medical grade silicone, Plott teaches wherein medical grade silicone comprises a Shore A hardness of between 10 and 50 (see Para. [0012] and [0069]).
Since Pinjala does not expressly disclose a Shore A hardness of the silicone used in the formation of the surgical stapler anvil, it would have been obvious to one of ordinary skill in the art to have looked to the prior art for a known Shore A hardness for medical grade silicone used to form surgical devices. It would have therefore been obvious to one of ordinary skill in the art to have modified the silicone used to form the anvil assembly of Ohdaira to comprise a Shore A hardness of between 10 and 50 as disclosed by Plott to be a known Shore A hardness for medical grade silicone.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable Ohdaira (US 2011/0095067 A1) in view of Sandstrom (US 2008/0249546 A1) (previously of record), further in view of Scifert (US 2007/0265632 A1) (previously of record), further in view of Salvermoser (US 2017/0252073 A1) (previously of record).
Regarding claim 30, the combination of Ohdaira, Sandstrom and Scifert disclose all of the limitations of the invention of claim 22.
However, none of the combination expressly discloses wherein the second handle includes a gripping member having a plurality of projections.
In the same field of endeavor, namely tissue manipulation devices, Salvermoser teaches wherein a handle (instrument 110, see Fig. 2) may comprise a plurality of ribs which represent raised portions in between open spaces or voids to allow for easier handling of the instrument (see Para. [0143]).
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 handle of the handle of the sizing device of Sandstrom, as incorporated into the device of Ohdaira, to include a plurality of raised portions along the length thereof to allow for easier handling of the instrument (see Salvermoser Para. [0143]).
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 2010/0089971 A1 to Milliman, US 2022/0160361 A1 to Busch, US 2004/0230155 A1 to Blanco and US 2005/0065543 A1 to Kahle all disclose surgical devices configured to contact tissue having a distal head portion having a tapered shape that aligns with the structure defined in claim 1.
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.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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