DETAILED ACTION
Claims 3-4 are canceled. Claims 1, 5-6, and 13 are amended. A complete action on the merits of pending claims 1-2 and 5-13 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/30/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner. However, Examiner noted, the 2nd NPL listed on the IDS was lined through and not considered seeing as how it failed to comply with 37 CFR 1.98(a)(3)(i) because it did not include a concise explanation of the relevance (or a translated copy (in English)), as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It was placed in the application file, but the information referred to therein was not considered.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 08/15/2025 in response to the Non-Final Office Action dated, 05/19/2025. The specification objections, 112(b) and 112(d) rejections documented in the Non-Final Office Action dated, 05/19/2025 are overcome through Applicant’s amendments and are now withdrawn.
Claim Rejections - 35 USC § 112
Claims 11-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11, which depends from claim 1, fails to comply with the requirements of 35 U.S.C. 112(d) because it does not specify a further limitation of the subject matter claimed in a non-redundant manner relative to its parent claim.
Claim 11 explicitly repeats limitations that are already fully present in the text of independent claim 1:
The recitation of "an internal surface suitable to be in contact with the biological tissue clamped by the first jaw and the second jaw;" and
The recitation of "the plurality of teeth being formed in the internal surface."
A dependent claim must inherently include all limitations of the parent claim by reference, and then introduce a new, narrowing limitation. By restating already claimed features, claim 11 is formally improper as it does not clearly delineate the additional scope restriction that separates it from claim 1.
Applicant may overcome this rejection by amending claim 11 to simply delete the repeated limitations. The claim should start immediately with the truly new limitations regarding the "external surface" and the "two external lateral portions," such as:
A surgical staple according to claim 1, wherein the first jaw has: an external surface opposite to the internal surface, and two lateral surfaces opposite to one another relative to the external surface, the two lateral surfaces comprising respectively two external lateral portions approaching one another until the external surface, in a direction running from the internal surface toward the external surface.
Claims 12-13 are rejected by virtue of their dependency on claim 11.
Claim Rejections - 35 USC § 103
Claim(s) 1 and 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodaczewski (US PGPUB No. 20170311954 A1), in view of Danitz (US PGPUB No. 20050059988 A1).
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Regarding claim 1, Brodaczewski discloses, a one piece molded polymeric ligating clip. Brodaczewski teaches, a surgical staple (Figure 1, clip (10); Paragraph [0037]) comprising a first jaw (Figure 1, lower leg (14); Paragraph [0037]) and a second jaw (Figure 1, upper leg (12); Paragraph [0037]) designed to pivot relative to one another around a pivot axis (Figure 1, axis at hinge (24); Paragraph [0037]) so as to clamp a biological tissue (Figure 7-11, vessel or duct (48); Paragraph [0040]), wherein the first jaw (lower leg (14)) comprises an internal surface (Figure 1, convex inner vessel clamping face (30); Paragraph [0038]) suitable for being in contact with the biological tissue clamped by the first jaw and the second jaw (Paragraph [0040]), two opposite lateral surfaces forming respectively (See annotated Figure 6 above, (Right & Left Lateral Surfaces)), with the internal surface (face (30)), a first edge (See annotated Figure 6 above, (First edge)) and a second edge (See annotated Figure 6 above, (Second edge)) opposite to the first edge relative to the internal surface (See annotated Figure 6 above), and a plurality of teeth (Figure 1, transverse ribs (56 & 58)) formed in the internal surface (face (30); Paragraph [0041]), the plurality of teeth (transverse ribs (56 & 58)) comprising:
a first tooth (Figures 4-6, rib (58)) having a first surface (See annotated Figure 6 above, (First Surface)) that is flat and inclined relative to the pivot axis in a section plane parallel to the pivot axis and passing through the first tooth (Figure 6; Paragraph [0042]), wherein the first surface (First Surface) extends up to the first edge (First Edge) (Under the broadest reasonable interpretation (BRI), The limitation 'wherein the first surface extends up to the first edge' is interpreted broadly to mean that the relevant functional portion of the tooth structure reaches the boundary defined as the 'first edge', and does not require a singular, continuous planar surface throughout its entire extent. The Reference discloses a rib (58) which functions as the claimed 'tooth'. This rib includes a 'sloped bevel tapered projection' (64) extending from a 'cylindrically curved base' (62). The examiner interprets the projection (64) as fulfilling the 'flat and inclined surface' limitation. Under the BRI, the projection (64), which is part of the overall rib (58) structure, is considered to 'extend up to the first edge' (See annotated Figure 6 above, (First edge)), because the entire rib acts as the single 'first tooth' structure in the reference. The curved base (62) is merely an intermediary portion of this single structure and does not defeat the broad interpretation of the surface's extent.), and
a second tooth (Figures 4 and 6, rib (56)) having a second surface (See annotated Figure 6 above, (Second surface)) that is flat and inclined relative to the pivot axis (Figure 6; Paragraph [0042]), wherein the second surface (Second Surface) extends up to the second edge (Second Edge) (Under the broadest reasonable interpretation (BRI), The limitation 'wherein the second surface extends up to the second edge' is interpreted broadly to mean that the relevant functional portion of the tooth structure reaches the boundary defined as the 'second edge', and does not require a singular, continuous planar surface throughout its entire extent. The Reference discloses a rib (56) which functions as the claimed 'tooth'. This rib includes a 'sloped bevel tapered projection' (64) extending from a 'cylindrically curved base' (62). The examiner interprets the projection (64) as fulfilling the 'flat and inclined surface' limitation. Under the BRI, the projection (64), which is part of the overall rib (56) structure, is considered to 'extend up to the second edge' (See annotated Figure 6 above, (Second edge)), because the entire rib acts as the single 'second tooth' structure in the reference. The curved base (62) is merely an intermediary portion of this single structure and does not defeat the broad interpretation of the surface's extent.),
wherein the first tooth (rib (58)) further comprises:
a third surface (See annotated Figure 5 below, (Third Surface)) that is inclined relative to the pivot axis (Figure 5), the third surface (Third Surface) being connected to the first surface (First Surface) (Figure 5; Paragraph [0042]), and
a fourth surface (See annotated Figure 5 below, (Fourth Surface)) that is inclined relative to the pivot axis (Figure 5), the third surface (Third Surface) and the fourth surface (Fourth surface) forming two slopes opposite to one another (Figure 5) relative to a tip (Figure 5, sharp point (66); Paragraph [0043]) of the first tooth (rib (58)).
Brodaczewski fails to teach, the first surface and the second surface being arranged to intersect in a section view of the first jaw in the section plane.
Danitz discloses, surgical clamps and clips that include engaging surfaces that provide increased traction on body tissues. Danitz teaches, a plurality of teeth (Figures 2A-2B, traction elements (200); Paragraph [0041]) comprising: a first tooth (See annotated Figure 2A below, (First tooth)) having a first surface that is flat and inclined (See annotated Figure 2A below, (First Surface)); a second tooth (See annotated Figure 2A below, (Second tooth)) having a second surface that is flat and inclined (See annotated Figure 2A below, (Second Surface)); and the first surface (First Surface) and the second surface (Second Surface) being arranged to intersect in a section view (Figure 2A; Paragraph [0023]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the Brodaczewski clip by replacing its tooth configuration with the intersecting teeth disclosed in Danitz, as both references and the claimed invention are directed to surgical ligating clips and clamps that provide secure clamping and traction on biological tissues. 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 Brodaczewski clip by replacing its tooth configuration with the intersecting teeth disclosed in Danitz, as such a modification would have been predictable, namely, to achieve enhanced gripping capability and reduce the likelihood of tissue slippage.
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Regarding claim 5, Brodaczewski further teaches, wherein the first tooth (rib (58)) has a tip (sharp point (66)) that is closer to the first edge than to the second edge (As seen in Figure 6, point (66) of rib (58) is indeed closer to the (First edge) than to the (Second edge)).
Regarding claim 6, Brodaczewski further teaches, wherein:
the first jaw (lower leg (14)) has an external surface (Figures 1-2, concave outer face (32); Paragraph [0038]) opposite to the internal surface (convex inner vessel clamping face (30)), and
the lateral surfaces (Right & Left Lateral Surfaces) comprise respectively two internal lateral portions (See annotated Figure 6 below, (Two Internal Lateral Potions)) flaring relative to one another until the first edge and the second edge in a direction running from the external surface toward the internal surface (As seen in Figure 6 the (Two Internal Lateral Portions) are indeed flaring relative to one another until the (First edge) and the (Second edge) in a direction running from the outer face (32) toward the inner face (30)).
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Regarding claim 7, Brodaczewski further teaches, wherein: one of the internal lateral portions has a tangent, at one point of the first edge, which is inclined by an angle relative to an axis parallel to the pivot axis, the angle being nonzero (See annotated Figure 6 below showing one of the (Two Internal Lateral Potions) having a tangent, at one point of the (First edge), which is inclined by an (Angle) relative to an axis parallel to the pivot axis, where the angle is clearly nonzero).
Further, Brodaczewski discloses the invention substantially as claimed, but does not explicitly disclose that the angle is strictly less than 90 degrees. Nevertheless, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the angle relative to an axis parallel to the pivot axis as desired, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges (e.g., the angle is strictly less than 90 degrees) involves only routine skill in the art. In re Aller.
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Regarding claim 8, Brodaczewski further teaches, wherein the plurality of teeth (transverse ribs (56 & 58)) comprises a third tooth (See annotated Figure 4 below, (Third tooth)), the third surface (Third Surface) being inclined relative to the pivot axis so as to be facing the third tooth (As was indicated in the annotated Figure 5 above (Paragraph [0026], “FIG. 5 is an enlarged scale isometric view of a single rib depicted in the circle 5 of FIG. 4.”), the (Third Surface) being a surface of cylindrically curved base (62) is indeed inclined relative to the pivot axis at hinge (24) so as to be facing the (Third tooth)).
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Regarding claim 9, Brodaczewski further teaches, wherein the second surface (Second Surface) extends between the first tooth (rib (58)) and the third tooth (Third tooth) (Given the arrangement of transverse ribs (56 & 58) (where the (Third tooth) is also a rib (58)) as seen in the Figures and as disclosed in Paragraph [0041], “Similarly the inner face 30 of the lower leg 14 includes two rows of transverse ribs 56, 58, with the rows separated from one another along the longitudinal center of the inner face of the lower leg 14. The ribs 56 of one row are staggered with respect to the ribs 58 of the other row as well as all ribs 50, 52 of the leg 12.” The (Second Surface) of rib (56) which is located between the rib (58) of Figure 5 and the (Third tooth) is indeed extending between the (rib (58)) and the (Third tooth)).
Regarding claim 10, Brodaczewski further teaches, wherein the second jaw (upper leg (12)) comprises a tooth (Figures 1-2, transverse ribs (50 & 52); Paragraph [0041]) arranged to extend between the first tooth (rib (58)) and the third tooth (Third tooth) (Paragraph [0041]), when the biological tissue (vessel or duct (48)) is clamped by the first jaw (lower leg (14)) and the second jaw (upper leg (12)) (Paragraph [0043]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodaczewski, in view of Danitz, and further in view of Howell (US Patent No. 6099539).
Regarding claim 2, Brodaczewski teaches, the first jaw (lower leg (14)).
Brodaczewski fails to teach, wherein the first surface and the second surface are arranged to intersect in the section view at a point located at mid-width of the first jaw, a width of the jaw being measured parallel to the pivot axis.
Danitz teaches, the first surface (First Surface) and the second surface (Second Surface) are arranged to intersect in the section view (Figure 2A).
Howell discloses, clamping members that include opposable resilient pads having surface protrusions where the protrusions of the opposing pads interdigitate to provide improved gripping of the occluded vessel or tubular structure. Howell teaches, a plurality of teeth (Figure 21, wedges (90); Col. 9, line 6-16) comprising: a first tooth (See annotated Figure 21 below, (First tooth)) having a first surface that is flat and inclined (See annotated Figure 21 below, (First surface)); a second tooth (See annotated Figure 21 below, (Second tooth)) having a second surface that is flat and inclined (See annotated Figure 21 below, (Second surface)); and the first surface (First surface) and the second surface (Second surface) are arranged to intersect in the section view (Figure 24; Col. 4, line 10-11) at a point located at mid-width of the first jaw (Figure 20, jaw (81); Col. 8, line 40-44 and Col. 8, line 65-Col. 9, line 16; As seen clearly in Figures 21 and 25-26, the (First surface) and the (Second surface) are indeed intersecting in a section view at a point located at mid-width of jaw (81)), a width of the jaw being measured parallel to the pivot axis (A width of jaw (81) taken as seen in Figures 25-26 is indeed taken/measured parallel to the pivot axis where the pivoting action of the surgical clip shown in Figures 20-26 is described in Col. 8, line 42-61).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the Brodaczewski clip by replacing its tooth configuration with the intersecting teeth disclosed in Danitz, in view of Howell, as all the references and the claimed invention are directed to surgical instruments for ligating vessels or clamping tissue. 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 Brodaczewski clip by replacing its tooth configuration with the intersecting teeth disclosed in Danitz, in view of Howell, as such a modification would have been predictable, namely, a person skilled in the art would have recognized that the specific tooth arrangement disclosed in Howell, which shows surfaces intersecting at a point located at the mid-width of the jaw (as taught in Howell and further reinforced by Danitz's teaching of intersecting surfaces), provides enhanced traction and secure closure compared to the general tooth structure in Brodaczewski.
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Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodaczewski, in view of Danitz, and further in view of Pierie (US Patent No. 3503396).
Regarding claim 11, Brodaczewski teaches, wherein the first jaw (lower leg (14)) has:
an internal surface (convex inner vessel clamping face (30); Paragraph [0038]) suitable to be in contact with the biological tissue clamped by the first jaw and the second jaw (Paragraph [0040]), the plurality of teeth (transverse ribs (56 & 58)) being formed in the internal surface (face (30); Paragraph [0041]),
an external surface (concave outer face (32); Paragraph [0038]) opposite to the internal surface (convex inner vessel clamping face (30)) (Paragraph [0038]), and
two lateral surfaces (Right & Left Lateral Surfaces) opposite to one another relative to the external surface (concave outer face (32)).
Brodaczewski fails to teach, the two lateral surfaces comprising respectively two external lateral portions approaching one another until the external surface, in a direction running from the internal surface toward the external surface.
Danitz teaches, aspects of the surgical staple according to claim 1 (See above rejection of claim 1).
Pierie discloses a surgical clamp system with modular, interchangeable jaw inserts. Pierie teaches, the two lateral surfaces comprising respectively two external lateral portions approaching one another until the external surface, in a direction running from the internal surface toward the external surface (Figures 12-13; Col. 5, line 17-19, disclose, “The side portions of element (62) comprise a pair of upstanding and slightly outwardly flaring flanges (64) equipped with teeth (50) in herringbone pattern.” Col. 5, line 22-25, discloses, “In FIGURE 13 the side flanges are of less flaring shape and this feature in combination with the previously described internal ridges 67 provides improved lateral stability.” This indicates that adjusting the degree of flare or convergence of lateral surfaces influence clamp stability and performance).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Brodaczewski’s clip arms to include external lateral portions that approach one another toward the external surface as taught by the design variations of Pierie, as all the references and the claimed invention are directed to surgical clamps/staples/clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodaczewski’s clip arms to include external lateral portions that approach one another toward the external surface as taught by the design variations of Pierie, as such a modification would have been predictable, namely, that such a design reduces the bulk of the instrument and improve ergonomics.
Regarding claim 12, Brodaczewski teaches, aspects of the surgical clip according to claim 11 (See above rejection of claim 11).
Brodaczewski fails to teach, wherein the external surface has a convex curved profile in the section plane, and the two external lateral portions have respective rectilinear profiles in the section plane.
Danitz teaches, other aspects of the surgical staple according to claim 1 (See above rejection of claim 1) from which claim 11 depends, which claim 12 depends upon.
Pierie teaches, the external surface has a convex curved profile in the section plane (Figures 12 and 13 illustrate jaw element (62) in cross-section as having a generally U-shaped profile with rounded corners at the base, corresponding to a convex curved external surface in the section plane), and the two external lateral portions have respective rectilinear profiles in the section plane (The side flanges (64) as seen in Figures 12-13 are extending as the sides of jaw element (62) and are depicted as rectilinear in the section plane, extending outwardly and slightly flaring relative to one another).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Brodaczewski’s clip arms, as previously modified to include external lateral portions that approach one another toward the external surface, to further incorporate a convex curved profile for the external surface and rectilinear profiles for the external lateral portions as taught by Pierie, as all the references and the claimed invention are directed to surgical clamps/staples/clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodaczewski’s clip arms, as previously modified to include external lateral portions that approach one another toward the external surface, to further incorporate a convex curved profile for the external surface and rectilinear profiles for the external lateral portions as taught by Pierie, as such a modification would have been predictable, namely, enhance ergonomic interaction and tissue conformity, reducing the risk of localized pressure points and ensuring a predictable interface with application tools.
Regarding claim 13, Brodaczewski teaches, aspects of the surgical clip according to claim 11 (See above rejection of claim 11).
Brodaczewski fails to teach, wherein the two external lateral portions continuously prolong the external surface.
Danitz teaches, other aspects of the surgical staple according to claim 1 (See above rejection of claim 1) from which claim 11 depends, which claim 12 depends upon.
Pierie teaches, the two external lateral portions continuously prolong the external surface (As shown in Figures 12 and 13, the flanges (64) are integrally formed with element (62), resulting in a smooth, continuous transition from the convex curved base to the rectilinear flanges, with no projections, interruptions, or roughness along the transition. Further, there is emphasis on the importance of maintaining smooth surfaces to prevent trauma and promote stability during use as disclosed in Col. 4, line 8-12).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Brodaczewski’s clip arms, as previously modified to include external lateral portions that approach one another toward the external surface, to ensure that the external lateral portions continuously prolong the external surface, consistent with the smooth, integral structure taught by Pierie, as all the references and the claimed invention are directed to surgical clamps/staples/clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodaczewski’s clip arms, as previously modified to include external lateral portions that approach one another toward the external surface, to ensure that the external lateral portions continuously prolong the external surface, consistent with the smooth, integral structure taught by Pierie, as such a modification would have been predictable, namely, enhance safety, reduce snagging, and improve interaction with both tissue and instruments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2 and 5-13 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.
See updated rejections above.
Conclusion
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771