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 .
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-4, 8-10, 13-15, 17-20 are rejected under 35 U.S.C. 102 or 103 as being unpatentable by De Cordoba (US 2023/0285069 A1)
Regarding claim 1, De Cordoba discloses an end effector 180 for a surgical tool 100, comprising: opposing first 182 and second jaws 184, and a knife slot 192 defined in one or both of the first and second jaws (Figs. 2-3; para. [0053]); and a monolithic knife 176 (i.e., see Fig. 3) comprising a drive rod 176 and a blade 178 distally extending from the drive rod (Fig. 3) and extendable through the knife slot (para. [0053]; Figs. 2-3), the drive rod and the blade being made from a same material (i.e., this is inherently disclosed since the drive rod and blade are monolithically formed (i.e., see Fig. 3 as well as paras. [0049]-[0050])), wherein the blade exhibits a thickness less than a thickness of the drive rod (see Figs. 2-3 and 5D which appears to show the edge 178 to be thinner than the rod; and para. [0049] which discloses the blade as a cutting edge)
However, even if Applicant agrees and argues that it is not explicitly disclosed that De Cordoba’s drive rod and blade is made from the same material, Examiner notes that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of the drive rod and the blade being made from the same material since the only two choices are [1) the drive rod and blade are made from the same material, or 2) the drive rod and blade are made from different materials]. These are the only two options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at the drive rod and blade being made from the same material.
Regarding the thickness of the blade, De Cordoba describes the cutting edge 178 being distinct from the knife member 176 such that the cutting edge is used to cut tissue (para. [0045]).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recognize that the tip of the knife member would need to be thinner than the drive rod for the purposes of creating a sharp edge capable of cutting tissue.
Regarding claim 2, De Cordoba discloses the end effector of claim 1. De Cordoba also discloses further comprising a hinge (i.e., see reproduced Fig. 3 below) interposing the blade and the drive rod (Fig. 3), wherein the hinge is integrally formed with the blade and the drive rod such that the hinge is made from the same material ((i.e., this is inherently disclosed since the hinge, drive rod, and blade are monolithically formed (i.e., see Fig. 3 as well as paras. [0049]-[0050]))).
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Regarding claim 3, De Cordoba discloses the end effector of claim 2. De Cordoba also discloses wherein the hinge and the drive rod exhibit an equal height that is less than a height of the blade (see Fig. 3 such that the hinge and the drive rod are the same height), and wherein the hinge and the blade exhibit an equal thickness (i.e., at least as shown in Fig. 3 since the hinge is the point at which the blade 178 and 176 engage).
Regarding claim 4, De Cordoba discloses the end effector of claim 2. De Cordoba doesn’t directly disclose wherein a thickness of the hinge is less than the thickness of the drive rod.
There is no evidence of record that establishes that changing the relative thickness of the hinge with regard to the drive rod would result in a difference in function of the De Cordoba device. Further, a person having ordinary skill in the art, being faced with modifying the knife assembly, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed relative thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, and the specification is silent with regard to the thickness of any of the cited components and therefore there appears to be no criticality placed on the dimension as claimed such that it produces an unexpected result.
Regarding claim 8, De Cordoba discloses the end effector of claim 1. De Cordoba also discloses wherein a leading edge of the blade includes a cutting edge 178 extending perpendicular to a sealing plane provided between the opposing first and second jaws when the opposing first and second jaws are closed (i.e., Figs. 2-5D).
Regarding claim 9 and 10, De Cordoba discloses the end effector of claim 1. De Cordoba also discloses wherein the drive rod exhibits a polygonal cross-sectional shape (i.e., rectangular as shown in Fig. 3).
Regarding claim 10, De Cordoba discloses the end effector of claim 9. De Cordoba doesn’t directly disclose wherein the polygonal cross-sectional shape is selected from the group consisting of an octagon, a hexagon, and a square.
De Cordoba does disclose a rectangular cross section as shown in Fig. 3.
There is no evidence of record that establishes that changing the shape of the drive rod would result in a difference in function of the De Cordoba device. Further, a person having ordinary skill in the art, being faced with modifying the knife assembly, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shape. Lastly, applicant has not disclosed that the claimed range solves any stated problem, and the specification is silent with regard to the shape of the drive rod (and even further claims broad polygonal shapes including octagon, hexagon, and square) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Regarding claim 13, De Cordoba discloses an end effector 180 for a surgical tool 100, comprising: opposing first 182 and second jaws 184, and a knife slot 192 defined in one or both of the first and second jaws (Figs. 2-3; para. [0053]); and a monolithic knife 176, 178 comprising: a drive rod 176 exhibiting a polygonal cross-sectional shape (Fig. 3); a hinge integrally extending from a distal end of the drive rod (i.e., as disclosed above and shown in Fig. 3 reproduced above); and a blade 178 distally extending from the hinge and being extendable through the knife slot (Fig. 3-5D), wherein the drive rod, the hinge, and the blade are integrally formed (Fig. 3) and made from a same material, and wherein the blade exhibits a thickness less than a thickness of the drive rod (see Figs. 2-3 and 5D which appears to show the edge 178 to be thinner than the rod; and para. [0049] which discloses the blade as a cutting edge).
De Cordoba doesn’t directly disclose that the drive rod and blade are made from the same material but does disclose that they are monolithic (para. [0049]-[0050]) and as shown in Fig. 3 being a monolithic knife assembly, such that if monolithically formed, the assembly would inherently be made from the same material).
Regarding the thickness of the blade, De Cordoba describes the cutting edge 178 being distinct from the knife member 176 such that the cutting edge is used to cut tissue (para. [0045]).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recognize that the tip of the knife member would need to be thinner than the drive rod for the purposes of creating a sharp edge capable of cutting tissue.
Regarding claim 14, De Cordoba discloses the end effector of claim 13. De Cordoba also discloses wherein the hinge and the drive rod exhibit an equal height (i.e., Fig. 3) that is less than a height of the blade (Fig. 3), and wherein the hinge and the blade exhibit an equal thickness (Fig. 3).
Regarding claim 15, De Cordoba discloses the end effector of claim 13. De Cordoba doesn’t directly disclose wherein a thickness of the hinge is less than the thickness of the drive rod.
There is no evidence of record that establishes that changing the relative thickness of the hinge with regard to the drive rod would result in a difference in function of the De Cordoba device. Further, a person having ordinary skill in the art, being faced with modifying the knife assembly, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed relative thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, and the specification is silent with regard to the thickness of any of the cited components and therefore there appears to be no criticality placed on the dimension as claimed such that it produces an unexpected result.
Regarding claim 17, De Cordoba and Yates disclose he end effector of claim 13. De Cordoba fails to directly disclose wherein the polygonal cross-sectional shape is octagonal.
There is no evidence of record that establishes that changing the shape of the drive rod would result in a difference in function of the De Cordoba device. Further, a person having ordinary skill in the art, being faced with modifying the knife assembly, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shape. Lastly, applicant has not disclosed that the claimed range solves any stated problem, and the specification is silent with regard to the shape of the drive rod (and even further claims broad polygonal shapes including octagon, hexagon, and square) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Regarding claim 18, De Cordoba discloses a method of operating a surgical tool 100, comprising: positioning the surgical tool adjacent a patient for operation (i.e., para. [0043] providing the tool for use prior to operation), the surgical tool including a drive housing 120, an elongate shaft 140 extending from the drive housing (Fig. 1), a drive rod 176 extending from the drive housing within the elongate shaft (para. [0046] Figs 1-3), and an end effector 180 arranged at a distal end of the elongate shaft (Fig. 1), the end effector including: opposing first 182 and second jaws 184; a knife slot 192 defined in one or both of the first and second jaws (Figs. 2-3; para. [0053]); and a blade 178 integrally extending from a distal end of the drive rod (Fig. 3) and extendable through the knife slot (Figs. 3-5D), the blade exhibiting a thickness less than a thickness of the drive rod (see Figs. 2-3 and 5D which appears to show the edge 178 to be thinner than the rod; and para. [0049] which discloses the blade as a cutting edge), closing the opposing first and second jaws and thereby grasping onto tissue between the opposing first and second jaws (para. [0046]); and actuating the drive rod to advance the blade through the knife slot and cut the tissue (para. [0053]).
De Cordoba doesn’t directly disclose that the drive rod and blade are made from the same material but does disclose that they are monolithic (para. [0049]-[0050]) and as shown in Fig. 3 being a monolithic knife assembly, such that if monolithically formed, the assembly would inherently be made from the same material.
However, even if Applicant agrees and argues that it is not explicitly disclosed that De Cordoba’s drive rod and blade is made from the same material, Examiner notes that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of the drive rod and the blade being made from the same material since the only two choices are [1) the drive rod and blade are made from the same material, or 2) the drive rod and blade are made from different materials]. These are the only two options apparent to one of ordinary skill in the art, with there being no undue experimentation and there being a reasonable expectation of success at arriving at the drive rod and blade being made from the same material.
Regarding claim 19, De Cordoba discloses the method of claim 18. De Cordoba also discloses wherein a leading edge of the blade includes a leading cutting edge (i.e., as shown in 178 of Fig. 3) extending perpendicular to a sealing plane provided between the opposing first and second jaws when the opposing first and second jaws are closed (Figs. 3-5D), the method further comprising: cutting tissue grasped between the opposing first and second jaws with the cutting edge as the blade advances through the knife slot (para. [0046]).
Regarding claim 20, De Cordoba discloses the method of claim 18. De Cordoba also discloses wherein the drive rod exhibits a polygonal cross-sectional shape (Fig. 3).
Claims 5-7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over De Cordoba in view of Whitlock et al. (US 20250009413 A1).
Regarding claim 5, De Cordoba discloses the end effector of claim 1. De Cordoba doesn’t directly disclose further comprising a distal extension that extends from a distal end of the drive rod and overlaps a portion of the blade.
In the same field of endeavor, namely instrument and end effector with jaw mechanism, Whitlock discloses a similar device to De Cordoba including two jaws 151, 152 with a channel 359 and knife assembly 380 (see Fig. 5) and also discloses a blade 381 and a distal extension 382 which extends from a distal end of the drive rod (Fig. 5) and overlaps a portion of the blade (i.e., note that Fig. 5 shows the sides of the blade being engaged with 382 such that the distal extension is overlapping a portion of the blade at least by being inserted into engagement with the blade).
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of De Cordoba to have an overlapping distal extension for purposes of ensuring attachment (i.e., or reinforcement by way of solder etc.) between the blade and drive rod (para. [0061])
Regarding claim 6, De Cordoba and Whitlock disclose the end effector of claim 5. De Cordoba doesn’t directly disclose the drive rod and the distal extension exhibit an equal thickness that is larger than a thickness exhibited by a remaining portion of the blade not overlapped by the distal extension.
There is no evidence of record that establishes that changing the relative thickness of the drive rod and distal extension with regard to the blade would result in a difference in function of the De Cordoba device. Further, a person having ordinary skill in the art, being faced with modifying the knife assembly, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed relative thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, and the specification is silent with regard to the thickness of any of the cited components and therefore there appears to be no criticality placed on the dimension as claimed such that it produces an unexpected result.
Additionally, De Cordoba discloses an equal thickness that is larger than a thickness exhibited by a remaining portion of the blade not overlapped by the distal extension (Fig. 5).
Regarding claim 7, De Cordoba and Whitlock disclose the end effector of claim 5. The combination of De Cordoba and Whitlock also discloses wherein the drive rod and the distal extension exhibit an equal height that is less than a height of the blade (i.e., as shown at least in Figs. 2-5D of De Cordoba).
Regarding claim 16, De Cordoba discloses the end effector of claim 13. De Cordoba fails to directly disclose a distal extension that extends from a distal end of the drive rod and overlaps a portion of the blade.
In the same field of endeavor, namely instrument and end effector with jaw mechanism, Whitlock discloses a similar device to De Cordoba including two jaws 151, 152 with a channel 359 and knife assembly 380 (see Fig. 5) and also discloses a blade 381 and a distal extension 382 which extends from a distal end of the drive rod (Fig. 5) and overlaps a portion of the blade (i.e., note that Fig. 5 shows the sides of the blade being engaged with 382 such that the distal extension is overlapping a portion of the blade at least by being inserted into engagement with the blade).
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of De Cordoba to have an overlapping distal extension for purposes of ensuring attachment (i.e., or reinforcement by way of solder etc.) between the blade and drive rod (para. [0061]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over De Cordoba in view of Yates et al. (US 2022/0387031 A1).
Regarding claims 11 and 12, De Cordoba discloses the end effector of claim 1. De Cordoba doesn’t directly disclose wherein the same material comprises nitinol, stainless steel, or titanium; wherein the monolithic knife assembly is manufactured via a process selected from the group consisting of photo chemical machining, machining where the same material comprises stainless steel or nitinol, direct laser metal sintering where the same material comprises nitinol, metal injection molding, additive manufacturing where the same material comprises a liquid metal.
In the same field of surgical cutting and fastening instrument, Yates discloses a similar device to De Cordoba including a surgical tool 2032 including an end effector 2012 that includes a knife bar 2200. Yates also disclose that the knife bar may be made from stainless steel (para. [0276]); wherein the monolithic knife assembly is manufactured via machining where the same material comprises stainless steel or nitinol (para. [0276]).
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 device of De Cordoba to be machined from stainless steel for the purposes of being sufficiently rigid to push the cutting instrument through tissue clamped in the end effector (para. [0276]).
Response to Arguments
Applicant's arguments filed April 07, 2026 have been fully considered but they are not persuasive. Applicant argues that De Cordoba doesn’t disclose that the blade has a thickness less than the drive rod and also argues criticality of the thickness as disclosed in Applicant’s specification at para. [0060]. Examiner agrees that the cited specification shows criticality, but that De Cordoba discloses at least in the figures (Figs. 2-3, 5D) a reduced thickness at 178 for the purposes of providing a cutting edge. Examiner notes that having a reduced thickness to provide a cutting edge is well known in the art and that having a drive rod with a reduced thickness is appropriate such that the rod can be advanced through De Cordobas jaws with enough strength to pierce tissue without breaking (thus the need for a thicker drive rod), but also a sharp edge to accomplish the piercing as a blunt edge would not sever tissue. As such, although not explicitly stated in De Cordoba’s description, the blade being a reduced thickness is shown in Figures 2-3 and 5D and one having ordinary skill in the art would be motivated to provide a sharp cutting edge that has a reduced thickness when compared to the drive rod.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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