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 9/18/2025 with regards to the amended limitations of “wherein the spine, the connecting web, and the contact sections are an integral structure” have been fully considered but they are not persuasive.
Regarding claim(s) 1, 15 and 18, Applicant contends that Hermann does not expressly show or disclose the limitations of “wherein the spine, the connecting web, and the contact sections are an integral structure” on the grounds that nothing in the disclosure of Hermann expressly recites, mentions or suggests that all of the recited components are formed as an integral structure.
The examiner respectfully disagrees with Applicant’s interpretation of the resulting structure of the insert of Hermann. As shown in Fig. 9A (the cross-section of the insert), provided below for reference, the spine, web portion and contact sections are molded together within overmold(s) 508 and 510 to form a single, unitary component of the insert member that is made up of the recited components. This can further be seen in that the spine and web portion are formed as a single, unitary component which is then embedded within the overmold 510 to which the contacting structure is integrated into as recited in Para. [0042]). As the term “integral structure”, without a more precise definition, is broadly interpreted to mean “a structure formed from different components into a single structure”, Hermann provides adequate disclosure in both the specification and disclosed drawings that the recited structure of the spine, web portion and contacting portion are fused together within the overmolds such that the resulting structure is a single, integral structure.
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Examiner’s Diagram of Hermann Fig. 9A
Additionally, regarding claim 1, Applicant contends that the Examiner’s interpretation of the “spine” and “connecting web/web portion” being separated by an “imaginary line” is beyond the allowable interpretable scope of the claimed invention as no set structure of defining feature separates the components.
The examiner respectfully disagrees. As no structure of function is presently claimed to delineate the two structures, the examiner’s interpretation is understood to be acceptable in light of the present claim language. Further, in the resulting structure, since the spine and web portions are integrated into a single, unitary component, additional structure of function is found to separate the two components. Lastly, the examiner notes that the claimed “web” is disclosed to be a distal portion of the spine surrounded by an overmold and is therefore understood to be an integral feature with the spine in light of the specification Para. [0055] and [0061]) which appears to be consistent with the currently-applied interpretation, until further amended to overcome such an interpretation.
Claim Objections
Applicant’s arguments, see “Remarks”, filed 9/18/2025, with respect to the claim objection to claim 15 for reciting “A clamp surface for an insert of a surgical clamp, comprising” have been fully considered and are persuasive in light of Applicant’s amendment to now recite “A clamp surface for an insert of a surgical clamp, the insert comprising” to make it clear the following limitations pertain to the insert specifically. The objection of claim 15 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 9/18/2025, with respect to the claim objection to claim 18 for reciting “around at least the connecting web and a portions of the contact portion”, which included a typographical error, have been fully considered and are persuasive in light of Applicant’s amendment to now recite “around at least the connecting web and a portion of the contact portion” to correct the typographical error. The objection of claim 18 has been withdrawn.
Claim Objections
Claim 15 and 18 are objected to because of the following informalities:
Claim 15 recites, in the amended limitations therein, “the connecting web” which should be corrected to recite “web portion” to remain consistent with the terminology of claim 15 introducing this feature.
Claim 18 recites, “the web” which should be corrected to recite “the connecting web” to remain consistent with the terminology of claim 18 introducing this feature.
Appropriate correction is required.
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) 15 and 18-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hermann (US 2005/0059987 A1)(previously of record).
Regarding claim 15, Hermann discloses:
A clamp surface (see Fig. 5A) for an insert of a surgical clamp (see Para. [0040] mentioning wherein the insert of Hermann is adhered to or bonded to a surgical clamp jaw), the insert comprising:
an elongate spine (see Examiner’s Diagram of Hermann Fig. 9A below denoting a spine as the portion of the insert not within overmold 510; the examiner notes that the diagram of Fig. 9A is disclosed to be a cross-section view of the embodiment of Fig. 5A as per Para. [0026]);
a plurality of contact sections (traction elements 504, see Fig. 9A) positioned along the elongate spine (see Examiner’s Diagram of Hermann Fig. 9A below showing the plurality of traction elements integrally connected to the spine to form the clamp insert, see Para. [0040]-[0042] mentioning wherein the insert is formed as an integral component via an overmold); and
a web portion extending between the elongate spine and spaced edges of the contact sections (see Examiner’s Diagram of Hermann Fig. 9A below showing a web portion as a portion of the insert structure embedded within overmold 510 that extends between the spine and contacting sections of the insert) to flexibly support the contact sections above the elongate spine (see Examiner’s Diagram of Hermann Fig. 9A below, see also Para. [0039] mentioning wherein the insert (i.e., the insert as a whole) maybe formed from rubber, neoprene, urethane, ethyl vinyl acetate foam, silicone, or silicone foam – all of which are flexible, elastomeric materials);
wherein the spine, the connecting web, and the contact sections are an integral structure (see Examiner’s Diagram of Hermann Fig. 9A below showing wherein the spine, web portion and contact sections are integral portions of the overall insert structure (i.e., the different components make up the greater structure of the insert); this can further be seen in that the spine and web portion are formed as a single, unitary component which is then embedded within the overmold 510 to which the contacting structure is integrated into as recited in Para. [0042]).
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Examiner’s Diagram of Hermann Fig. 9A
Regarding claim 18, Hermann discloses:
A method for making an insert for a surgical clamp (see Figs. 5A and 9A, see also Para. [0039] - [0041]), comprising:
forming an integral structure (structure of the insert shown in Fig. 9A) having a spine (see Examiner’s Diagram of Hermann Fig. 9A above denoting a spine as the portion of the insert not within overmold 510, see also Para. [0041]-[0042] mentioning wherein the inserts of Hermann may be molded directly onto surgical instruments and wherein traction elements are integrally formed therewith), a connecting web (see Examiner’s Diagram of Hermann Fig. 9A above showing a connecting web (indicated as “web portion”) as an upper portion of the spine structure embedded within overmold 510), and a contact portion (traction elements 504 and their mounting base, see Fig. 9A) (see Examiner’s Diagram of Hermann Fig. 9A above showing wherein the spine, connecting web and contact sections are integral portions of the overall insert structure (i.e., the different components make up the greater structure of the insert); this can further be seen in that the spine and connecting web are formed as a single, unitary component which is then embedded within the overmold 510 to which the contacting structure is integrated into as recited in Para. [0042]);
wherein the spine is an elongate structure having a lower surface defining structure to engage a jaw of the clamp (see Examiner’s Diagram of Hermann Fig. 9A above; as the traction elements 504 are configured to contact tissue (see Para. [0012] and [0025]), the opposing end, denoted as “distal engagement section” is understood to be attachable to a jaw of a surgical clamp);
the contact portion has a textured surface configured to contact tissue (traction elements 504, see Para. [0012]); and
the web extends between an upper surface of the spine and the contact portion (see Examiner’s Diagram of Fig. 9A above showing wherein the connecting web (i.e., “web portion”) extends between the spine and the contact portion, connected via the overmolds 508/510) and flexibly supports the contact portion above the upper surface of the spine (see Examiner’s Diagram of Hermann Fig. 9A above, see also Para. [0039] mentioning wherein the insert (i.e., the insert as a whole) maybe formed from rubber, neoprene, urethane, ethyl vinyl acetate foam, silicone, or silicone foam – all of which are flexible, elastomeric materials); and
forming an overmold (overmolds 508 and 510, see Fig. 9A; the examiner notes that the overmolds may be provided as either a single, or separate overmolds per Para. [0041]) around at least the connecting web and a portion of the contact portion (see Examiner’s Diagram of Hermann Fig. 9A above) while leaving the textured surface exposed (see Fig. 5A and 9A showing wherein traction members 504 are exposed from each of the openings within the overmold).
Regarding claim 19, Hermann discloses the method of claim 18, Hermann further discloses wherein the step of forming the overmold comprises forming the overmold having a series of windows through which the textured surface is exposed (see Fig. 5A showing wherein rectangles 500 allow the traction elements to extend therethrough and thus constitute windows).
Regarding claim 20, Hermann discloses the method of claim 19, Hermann further discloses wherein the textured surface comprises a series of textured surfaces defined along a length of the contact portion (see Fig. 9A), and wherein the series of windows are arranged along a length of the overmold to coincide with the series of textured surfaces (see Fig. 5A, see also Para. [0026] mentioning wherein Fig. 9A is a cross-section of Fig. 5A taken along line 5-5).
Regarding claim 21, Hermann discloses the method of claim 19, Hermann further discloses wherein the integral structure has openings between the contact portion and the spine (see Fig. 9A showing a gap between the spine and traction elements 504, filled in by overmolds 508 and 510), and wherein the step of forming the overmold comprises forming the overmold through the openings (see Fig. 9A, see also Para. [0040]-[0041]; the examiner notes that the overmold connects the spine to the traction elements as shown in Fig. 9A).
Regarding claim 22, Hermann discloses the method of claim 19, Hermann further discloses wherein the steps of forming the integral structure and forming the overmold comprise injection molding the integral structure, and then injection molding the overmold (see Para. [0040] mentioning wherein the inserts are injection molded onto surgical instruments, taken to mean wherein the inserts are formed separately before being overmolded onto said surgical instruments to attach the two elements together which forms the resulting integral structure).
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) 1-14 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hermann (US 2005/0059987 A1)(previously of record) in view of Gee (US 2021/0196353 A1)(previously of record).
Regarding claim 1, Hermann discloses:
An insert for a surgical clamp (insert 506, see Fig. 9A), comprising:
an integral structure having a spine (see Examiner’s Diagram of Hermann Fig. 9A below denoting a spine as the portion of the insert not within overmold 510; the examiner notes that the diagram of Fig. 9A is disclosed to be a cross-section view of the embodiment of Fig. 5A as per Para. [0026]), a connecting web (see Examiner’s Diagram of Hermann Fig. 9A below denoting a connecting web (denoted as “web portion”) as the portion of the insert structure embedded within overmold 510; the examiner notes that the claimed “web” is disclosed to be a distal portion of the spine surrounded by an overmold and is therefore understood to be an integral feature with the spine in light of the specification Para. [0055] and [0061]), and a contact portion (traction elements 504 and its mounting base, see Fig. 9A);
the contact portion has a textured surface configured to contact tissue (traction elements 504, see Fig. 9A, see also Para. [0030]); and
wherein the web extends between an upper surface of the spine and the contact portion (see Examiner’s Diagram of Fig. 9A below showing wherein the web extends between the spine and the contact portion, connected via the overmolds 508/510) and flexibly supports the contact portion above the upper surface of the spine (see Examiner’s Diagram of Hermann Fig. 9A below, see also Para. [0039] mentioning wherein the insert (i.e., the insert as a whole) maybe formed from rubber, neoprene, urethane, ethyl vinyl acetate foam, silicone, or silicone foam – all of which are flexible, elastomeric materials).
However, while Hermann discloses wherein the insert is configured to be mounted onto a surgical clamping device (see Para. [0030]) and wherein the web supports the contact portion above the upper surface of the spine (see Examiner’s Diagram of Hermann Fig. 9A below), Hermann does not expressly disclose:
wherein the spine is an elongate structure having a lower surface defining structure to engage a jaw of the clamp.
In the same field of endeavor, namely inserts for surgical clamping devices, Gee teaches wherein an insert for a surgical clamp (pad 7080, see Fig. 126A) comprising an elongate spine (“I” portion between first crossbar 7083 and second crossbar 7085, see Fig. 126A) for connecting tissue contacting elements (pad 7084, see Fig. 126A) which is configured to attach the pad to a jaw (jaw 7081, see Fig. 126A) of a surgical clamping device to form a single structure in a snap-fit manner (see Para. [0506] – the examiner notes that the snap-fit configuration of the “I-beam” is also disclosed to be present in the embodiment of Figs. 126A-126B per Para. [0506]).
Since Hermann discloses wherein the insert is mountable within a surgical clamp, but is silent in regards to a method of attachment, one of ordinary skill would have looked to the prior art to provide a known method of attaching surgical clamp inserts to surgical clamps. 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 configured the spine of Hermann to comprise an “I-beam” shape which is to be insertable into a channel within a jaw clamp, as taught by Gee, to provide a known method of attachment between the clamp insert and the clamp jaw in a snap-fit manner (see Gee Para. [0506]).
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Examiner’s Diagram of Hermann Fig. 9A
Regarding claim 2, the combination of Hermann and Gee disclose all of the limitations of the invention of claim 1.
However, the combination as currently presented does not expressly disclose wherein the web comprises a series of columns connected between the upper surface of the spine and a lower surface of the contact portion.
Gee teaches wherein inserts for a clamping device (pads 2732, see Fig. 55) which may be either individual units or a single unitary pad (see Para. [0222]) are insertable into a jaw of a clamping device (see Fig. 57, see also Para. [0341]), each pad comprising a spine (pad tip 2750, see Fig. 55) and a web (pad neck 2746, see Fig. 55), wherein each pad web is separated from adjacent pads by a gap (see Fig. 57 – noting that as each pad is an individual element inserted independently into a jaw, each pad is separated by a distance from adjacent pads).
Since Hermann discloses wherein the “webs” connect the base spine to tissue engaging elements, but is silent in regards to a method of attachment and/or arrangement, one of ordinary skill would have looked to the prior art to provide a known method of attaching surgical clamp inserts to surgical clamps. 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 configured the webs of Hermann to be separate, individual elements as taught by Gee connecting to each of the “rectangles 500” shown in Fig. 5A, to provide a known method of connection between each adjacent rectangle engaging element. The examiner notes that each “rectangle” is disclosed to be connected to adjacent rectangles via narrower section 502 (see Para. [0044]) which is the only disclosed attachment between adjacent rectangles, providing lateral flexibility of the insert (see Para. [0044]). Therefore, in keeping with the benefit of allowing for increased lateral flexibility, one of ordinary skill in the art would have expected adjacent rectangles to function properly with the base web portions separated by a distance from one-another, with the only connection between adjacent rectangles being narrow sections 502.
Regarding claim 3, the combination of Hermann and Gee disclose the invention of claim 2, Hermann further discloses wherein the contact portion comprises an elongate structure (see Fig. 5A – noting that each “rectangle” 500 is comprises traction elements 504 as the cross section of Fig. 9A is taken along a line (5-5) of Fig. 5A, see Para. [0048]) comprising a series of laterally extending sections defining contact surfaces having gripping contours (rectangles 500 comprising traction elements 504, see Fig. 5A), and intervening laterally narrower connecting sections (narrower spines 502, see Fig. 5A) between the laterally extending sections (see Para. [0044], see also Fig. 5A).
Regarding claim 4, the combination of Hermann and Gee disclose the invention of claim 3, Hermann, as modified by Gee, further discloses wherein the columns connect between the upper surface of the spine and a lower surface of the laterally narrower connecting sections (the columns of Hermann, as incorporated from the device of Gee, connect between the traction elements and the spine forming the base of the web portion, see Examiner’s Diagram of Hermann Fig. 9A above) whereby each laterally extending section extends between adjacent columns (see Fig. 5A showing wherein each rectangle extends to each adjacent rectangle via narrower spine 502) whereby the laterally extending section has vertical flexibility relative to the spine (as the insert of Hermann is disclosed to be made from elastomeric materials (see Para. [0039]), the rectangles comprise vertical flexibility via the connecting web portions due to the elastomeric materials listed in Para. [0039]).
Regarding claim 5, the combination of Hermann and Gee disclose the invention of claim 1, Hermann further discloses an overmold (overmolds 508 and 510, see Fig. 9A – the examiner notes that the overmolds may be provided as either a single, or separate overmolds per Para. [0041]) surrounding at least the web (see Fig. 9A) and portions of the contact portion (see Fig. 9A), the overmold having a series of windows (see Fig. 5A showing wherein rectangles 500 allow the traction elements to extend therethrough and thus constitute windows), and the contact portion having a series of textured surface sections exposed through the series of windows (see Fig. 5A showing wherein traction members 504 are exposed from each of the openings within the overmold). The examiner additionally notes that the arrangement of the windows and exposed traction elements may be in the form of any of those shown in Figs. 4A-8B per the disclosure of Hermann in Para. [0042].
Regarding claim 6, the combination of Hermann and Gee disclose the invention of claim 4, Hermann further discloses an overmold (overmolds 508 and 510, see Fig. 9A – the examiner notes that the overmolds may be provided as either a single, or separate overmolds per Para. [0041]) surrounding at least the web (see Fig. 9A) and portions of the contact portion (see Fig. 9A), the overmold having a series of windows aligned with the laterally extending sections of the contact portion (see Fig. 5A showing wherein rectangles 500 allow the traction elements to extend therethrough and thus constitute windows).
Regarding claim 7, the combination of Hermann and Gee disclose the invention of claim 6, Hermann, as modified by Gee, further discloses wherein the web defines lateral gaps (each rectangle 500 comprises its own web portion, as incorporated from the device of Gee), and wherein the overmold extends through the lateral gaps to engage the spine (as the inserts are injection molded onto surgical instruments, the overmold section would fill in any gaps between components within the insert apparatus during material injection).
Regarding claim 8, the combination of Hermann and Gee disclose the invention of claim 6, Hermann further discloses wherein the overmold comprises an elastomeric material (see Para. [0039]) having a durometer of between 20 and 65 Shore A (see Para. [0039 and 0041] mentioning wherein the elastomeric material may comprise a shore hardness between 0-95A Shore).
However, while Hermann discloses wherein the overmold comprises a durometer overlapping the claimed range, Hermann does not expressly disclose wherein the durometer of the overmold is confined to the claimed range.
However, 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 durometer of the overmold of Hermann to be within a range of 20 and 65 Shore A, which is the selection of the overlapping portion of the claimed range and the prior art range, as applicant appears to have placed no criticality on the claimed range (see pp. [0012] indicating the durometer “can” be within the claimed range in a “non-limiting example” (see Spec. Para. [0017] and [0051]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, the combination of Hermann and Gee disclose the invention of claim 8, Hermann further discloses wherein the overmold comprises a silicone material (see Para. [0039 and 0041] mentioning wherein one of the optional elastomeric materials used to construct the insert may be silicone).
Regarding claim 10, the combination of Hermann and Gee disclose all of the limitations of the invention of claim 1.
However, the combination as currently presented does not expressly disclose wherein the structure for engaging the jaw of the clamp comprises a series of engagement segments separated by gaps.
However Gee teaches wherein inserts for a clamping device (pads 2732, see Fig. 55) which may be either individual units or a single unitary pad (see Para. [0222]) are insertable into a jaw of a clamping device (see Fig. 57, see also Para. [0341]), each pad comprising a spine (pad tip 2750, see Fig. 55) and a web (pad neck 2746, see Fig. 55), wherein each pad web is separated from adjacent pads by a gap (see Fig. 57 – noting that as each pad is an individual element inserted independently into a jaw, each pad is separated by a distance from adjacent pads).
Since Hermann discloses wherein the “webs” connect the base spine to tissue engaging elements, but is silent in regards to a method of attachment and/or arrangement, one of ordinary skill would have looked to the prior art to provide a known method of attaching surgical clamp inserts to surgical clamps. 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 configured the webs of Hermann to be separate, individual elements as taught by Gee connecting to each of the “rectangles 500” shown in Fig. 5A, to provide a known method of connection between each adjacent rectangle engaging element. The examiner notes that each “rectangle” is disclosed to be connected to adjacent rectangles via narrower section 502 (see Para. [0044]) which is the only disclosed attachment between adjacent rectangles, providing lateral flexibility of the insert (see Para. [0044]). Therefore, in keeping with the benefit of allowing for increased lateral flexibility, one of ordinary skill in the art would have expected adjacent rectangles to function properly with the base web portions separated by a distance from one-another, with the only connection between adjacent rectangles being narrow sections 502.
Regarding claim 11, the combination of Hermann and Gee disclose the invention of claim 10, Hermann, as modified by Gee, further discloses wherein the structure for engaging the jaw of the clamp further comprises a distal engagement segment positioned at a distal end of the lower portion of the spine (see Examiner’s Diagram of Hermann Fig. 9A_Distal below showing a distal engagement segment positioned at the lower portion of the spine that would engage with a jaw when mounted thereon, as disclosed by Gee as a known attachment mechanism, incorporated into the device of Hermann. The examiner notes that the base of the spine has been modified to be in the form of a rectangle to be in similar form to the spine of Gee when incorporating the connection mechanism therefrom).
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Examiner’s Diagram of Hermann Fig. 9A_Distal
Claim 12, the combination of Hermann and Gee disclose all of the limitations of the invention of claim 1, Hermann, as modified by Gee further discloses wherein the distal engagement segment is longer than the engagement segments (see Examiner’s Diagram of Fig. 9A_Distal above designating a “Distal Engagement Section” that is longer than an “Engagement Section” – the examiner notes that as the spine/web portion is defined to be an “integral” structure (see Claim 1), the claimed sections are understood to merely be delineations along the length of the integral spine/web structure and such a designation, as noted above in Examiner’s Diagram of Fig. 9A_Distal is within the scope of the currently-provided claim language), and has a flat distal end (as the “I-beam” structure of Gee was incorporated into the device of Hermann (see rejection of Claim 1), the distal end of the spine of Hermann comprises a flat end to allow for the snap-fit securement taught by Gee), whereby the flat distal end snaps into place when inserted into a jaw channel (see Gee Para. [0506], as incorporated into the device of Hermann to provide a known attachment mechanism for securing the insert to a jaw or a surgical clamping device).
Regarding claim 13, the combination of Hermann and Gee disclose the invention of claim 1, Hermann further discloses wherein the spine, the web and the contact portion are a single unitary component (see Para. [0041 and 0042] mentioning wherein the insert, including the traction elements, may be injection molded directly into surgical instruments, including the traction elements, constituting a single unitary structure formed from a single material as per Para. [0039]).
Regarding claim 14, the combination of Hermann and Gee disclose all of the limitations of the invention of claim 1.
However, while Hermann discloses wherein the traction elements may be formed from a variety of thermoplastic or thermosetting polymers such as polyethylene, polypropylene, nylons, melamine, polystyrenes, polycarbonates, various fluorinated polymers, epoxy resin, cellulose acetate, vinyl chloride polymers, and copolymers or blends thereof (see Para. [0038]) and wherein the inserts themselves are formed from compliant and deflectable elastomers, preferably thermoplastic elastomers (see Para. [0039]), which overlap in terms of acceptable polymers (i.e., nylon and polyethylene which are both compliant and deflectable), Hermann does not expressly disclose wherein the spine, the web and the contact portion all comprise the same material.
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 being obvious to try (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007)) to have obtained the predictable result of having both the insert and traction elements of the device of Hermann be formed from the same thermoplastic material capable of being injection molded, since Hermann discloses wherein both elements are formed from injectable thermoplastic polymers (see Para. [0039-0039]). It is held to be obvious to one of ordinary skill in the art to have selected from a finite number of options in forming the traction elements and insert and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin 125 USPQ 416. Since both the traction elements and insert of Hermann are disclosed to be formed from the same family of injectable thermoplastic materials, it would have been obvious to one of ordinary skill in the art to have selected from the finite number of listed materials within the disclosure of Hermann to have formed the two components from, and to have chosen the same material for both components.
Regarding claim 16, Hermann discloses the invention of claim 15, Hermann further discloses wherein the elongate spine defines a longitudinal axis (see Examiner’s Diagram of Fig. 9A above showing a longitudinal axis defined by the spine), and wherein the contact sections are arranged along the longitudinal axis (see Examiner’s Diagram of Fig. 9A above) and connection portions (spines 502, see Fig. 5A).
However, Hermann does not expressly disclose wherein the web portion comprises a series of columns extending between the upper surface of the spine and the connection portions, and wherein connection portions extend between each of a plurality of contact sections.
However, in the same field of endeavor, namely inserts for surgical jaw devices, Gee teaches wherein inserts for a clamping device (pads 2732, see Fig. 55) which may be either individual units or a single unitary pad (see Para. [0222]) are insertable into a jaw of a clamping device (see Fig. 57, see also Para. [0341]), each pad comprising a spine (pad tip 2750, see Fig. 55) and a web (pad neck 2746, see Fig. 55), wherein each pad web is separated from adjacent pads by a gap (see Fig. 57 – noting that as each pad is an individual element inserted independently into a jaw, each pad is separated by a distance from adjacent pads).
Since Hermann discloses wherein the “webs” connect the base spine to tissue engaging elements, but is silent in regards to a method of attachment and/or arrangement, one of ordinary skill would have looked to the prior art to provide a known method of attaching surgical clamp inserts to surgical clamps. 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 configured the webs of Hermann to be separate, individual elements as taught by Gee connecting to each of the “rectangles 500” shown in Fig. 5A, to provide a known method of connection between each adjacent rectangle engaging element. The examiner notes that each “rectangle” is disclosed to be connected to adjacent rectangles via narrower section 502 (see Para. [0044]) which is the only disclosed attachment between adjacent rectangles, providing lateral flexibility of the insert (see Para. [0044]). Therefore, in keeping with the benefit of allowing for increased lateral flexibility, one of ordinary skill in the art would have expected adjacent rectangles to function properly with the base web portions separated by a distance from one-another, with the only connection between adjacent rectangles being narrow sections 502. The examiner notes that “spines 502” of Hermann would extend between adjacent web portions and would thus extend between adjacent contact portions positioned atop each web portion.
Regarding claim 17, the combination of Hermann and Gee disclose the invention of claim 16, Hermann further discloses wherein the connection portions are laterally narrower than the contact sections (see Fig. 5A, see also Para. [0044]).
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 2020/0138443 A1 to Macneil, US 3503397 A to Raible, US 3503398 A to Fogarty and US 4821719 A to Fogarty all disclose surgical clamp inserts having a web portion, a spine and a tissue contacting portion configured for coupling with a surgical clamp jaw.
THIS ACTION IS MADE FINAL. 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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/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771