DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a web” and “an arm”, along with all associated claimed features for these limitations must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 21, “the firing beam comprises: a web; . . . and an arm mounted to the firing beam, wherein the arm is movable with the firing beam during the staple firing motion and is selectively movable into the cavity” fails to comply with the written description requirement because the originally filed disclosure does not support these limitations. The specification, drawings, and originally filed claims do not describe a web or an arm performing the functions listed in the claim.
Regarding claims 22-26 and 29, these claims fail to comply with the written description requirement because the originally filed disclosure does not support the limitations in these claims. For example, the specification, drawings, and originally filed claims do not describe the arm is selectively pivotable into the cavity, as claimed in claim 22, or that the arm is pivotable about a fixed point, as claimed in claim 23.
Regarding claim 30, “the actuator comprises: . . . an arm mounted to the actuator, wherein the arm is movable with the actuator during the staple firing motion, and wherein at least a portion of the arm is selectively movable into the cavity” fails to comply with the written description requirement because the originally filed disclosure does not support these limitations. The specification, drawings, and originally filed claims do not describe a web or an arm performing the functions listed in the claim.
Regarding claims 31-35, these claims fail to comply with the written description requirement because the originally filed disclosure does not support the limitations in these claims. For example, the specification, drawings, and originally filed claims do not describe at least a portion of the arm is selectively movable about a pivot, as claimed in claim 31, or that the pivot is a fixed pivot, as claimed in claim 32.
Regarding claim 21, “the firing beam comprises: a web; . . . and an arm mounted to the firing beam, wherein the arm is movable longitudinally with the firing beam during the staple firing motion, and wherein at least a portion of the arm is selectively rotatable into the cavity” fails to comply with the written description requirement because the originally filed disclosure does not support these limitations. The specification, drawings, and originally filed claims do not describe a web or an arm performing the functions listed in the claim.
Regarding claims 37-39, these claims fail to comply with the written description requirement because the originally filed disclosure does not support the limitations in these claims. For example, the specification, drawings, and originally filed claims do not describe at least a portion of the arm is selectively pivotable about a pivot, as claimed in claim 37, or that the pivot is a fixed pivot, as claimed in claim 38.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21, claim 21 is indefinite because it is unclear if the arm is a component of the firing beam or a separate component from the firing beam. Based on the way in which the claim is structured (the claim includes “wherein the firing beam comprises. . .” and an indented list of elements of the firing beam), the claim is written as though the arm is a component of the firing beam. However, the description of the arm includes “the arm is movable with the firing beam”, indicating that the arm is a separate element and not part of the entire firing beam system. For examination purposes, the arm is being treated as a separate element from the firing beam, but is capable of moving with the firing beam.
Regarding claims 22-29, claims 22-29 are rejected because they depend from rejected claim 21.
Regarding claim 30, claim 30 is indefinite because it is unclear if the arm is a component of the actuator or a separate component from the actuator. Based on the way in which the claim is structured (the claim includes “wherein the actuator comprises. . .” and an indented list of elements of the actuator), the claim is written as though the arm is a component of the actuator. However, the description of the arm includes “the arm is movable with the actuator”, indicating that the arm is a separate element and not part of the entire actuator system. For examination purposes, the arm is being treated as a separate element from the actuator, but is capable of moving with the actuator.
Regarding claims 31-35, claims 31-35 are rejected because they depend from rejected claim 30.
Regarding claim 36, claim 36 is indefinite because it is unclear if the arm is a component of the firing beam or a separate component from the firing beam. Based on the way in which the claim is structured (the claim includes “wherein the firing beam comprises. . .” and an indented list of elements of the firing beam), the claim is written as though the arm is a component of the firing beam. However, the description of the arm includes “the arm is movable with the firing beam”, indicating that the arm is a separate element and not part of the entire firing beam system. For examination purposes, the arm is being treated as a separate element from the firing beam, but is capable of moving with the firing beam.
Regarding claims 37-40, claims 37-40 are rejected because they depend from rejected claim 36.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21-28, 30-34, and 36-40 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Ortiz et al (US 2007/0102475), hereinafter Ortiz.
Regarding claim 21, Ortiz discloses a surgical tool (Fig. 1, item 10), comprising:
an end effector (Fig. 2, item 20) movable between an open configuration (Para. 0032) and a closed configuration (Para. 0032), wherein the end effector comprises:
an elongate channel (Fig. 2, item 40), wherein a cavity (Fig. 4, cavity is interior of channel 40) is defined in the elongate channel; and
an anvil (Fig. 2, item 42);
a firing beam (Fig. 4, item 226, 66, 170, 165, 166, 172, 176) movable through the end effector during a staple firing motion (Para. 0044-0049, staple firing motion can be when sled is properly placed in the cartridge or when the sled is not located in the cartridge), wherein the firing beam comprises:
a web (Fig. 11, item 165);
a first cam (Fig. 11, item 170) extending from the web, wherein the first cam is positioned (Fig. 11) and structured to engage the elongate channel (Para. 0040);
a second cam (Fig. 11, item 166) extending from the web, wherein the second cam is positioned (Fig. 11) and structured to engage the anvil (Para. 0040); and
an arm (Fig. 8, item 226) mounted to the firing beam (Fig. 8, lockout 226 is mounted to firing beam because it is attached to the firing beam), wherein the arm is movable with the firing beam during the staple firing motion (Para. 0044-0049, lockout 226 moves as firing beam tries to moves in staple firing motion if the sled is not properly located in cartridge) and is selectively movable into the cavity (Para. 0044-0049).
Regarding claim 22, Ortiz discloses the surgical tool of claim 21, wherein the arm is selectively pivotable into the cavity (Para. 0044).
Regarding claim 23, Ortiz discloses the surgical tool of claim 22, wherein the arm is pivotable about a fixed pivot (Fig. 8, item 232) (Para. 0044).
Regarding claim 24, Ortiz discloses the surgical tool of claim 21, wherein the arm comprises a distal-facing surface (Fig. 8, item 228, 238) positionable to engage the cavity (Para. 0045).
Regarding claim 25, Ortiz discloses the surgical tool of claim 24, wherein the cavity comprises an end wall (Fig. 8, item 40) (Para. 0045) positioned to exert a force (Para. 0045) on the distal-facing surface (Para. 0045) when the arm is positioned in the cavity (Para. 0045) and the firing beam is being advanced distally (Para. 0045).
Regarding claim 26, Ortiz discloses the surgical tool of claim 24, wherein the arm comprises a first arm (Fig. 8, item 238), wherein the firing beam further comprises a second arm (Fig. 4, item 68), and wherein the first arm and the second arm are movable independently (Para. 0044-0049, firing beam 66, 68 can slide longitudinally when lockout 226 is disengaged from firing beam).
Regarding claim 27, Ortiz discloses the surgical tool of claim 21, wherein the firing beam further comprises a knife (Fig. 8, item 176).
Regarding claim 28, Ortiz discloses the surgical tool of claim 21, wherein the firing beam further comprises a distal wedge (Fig. 4, item 180).
Regarding claim 30, Ortiz discloses a surgical tool (Fig. 1, item 10), comprising:
an end effector (Fig. 2, item 20) movable between an open configuration (Para. 0032) and a closed configuration (Para. 0032), wherein the end effector comprises:
a first jaw (Fig. 2, item 40), wherein a cavity (Fig. 4, cavity is interior of channel 40); and
a second jaw (Fig. 2, item 42);
an actuator (Fig. 4, item 226, 66, 170, 165, 166, 172, 176) movable through the end effector during a staple firing motion (Para. 0044-0049, staple firing motion can be when sled is properly placed in the cartridge or when the sled is not located in the cartridge), wherein the actuator comprises:
a body (Fig. 11, item 165);
a first cam (Fig. 11, item 170) extending from the body (Fig. 11), wherein the first cam is positioned (Fig. 11) and structured to engage the first jaw (Para. 0040);
a second cam (Fig. 11, item 166) extending from the body (Fig. 11), wherein the second cam is positioned (Fig. 11) and structured to engage the second jaw (Para. 0040); and
an arm (Fig. 8, item 226) movably mounted to the actuator (Fig. 8, lockout 226 is mounted to firing beam because it is attached to the firing beam), wherein the arm is movable with the actuator during the staple firing motion (Para. 0044-0049, lockout 226 moves as firing beam tries to moves in staple firing motion if the sled is not properly located in cartridge), and wherein at least a portion of the arm is selectively movable into the cavity (Para. 0044-0049).
Regarding claim 31, Ortiz discloses the surgical tool of claim 30, wherein at least the portion of the arm is selectively movable relative to the actuator about a pivot (Fig. 8, item 232) (Para. 0044).
Regarding claim 32, Ortiz discloses the surgical tool of claim 31, wherein the pivot comprises a fixed pivot (Fig. 8, item 232) (Para. 0044).
Regarding claim 33, Ortiz discloses the surgical tool of claim 30, wherein the arm comprises a distal-facing surface (Fig. 8, item 228, 238) positionable to engage the cavity (Para. 0045), and wherein the body further comprises a distal-facing knife edge (Fig. 8, item 176).
Regarding claim 34, Ortiz discloses the surgical tool of claim 33, wherein the cavity comprises an end wall (Fig. 8, item 40) (Para. 0045) positioned to exert a force (Para. 0045) on the distal-facing surface (Para. 0045) when at least the portion of the arm is positioned in the cavity (Para. 0045) and the actuator is being advanced distally (Para. 0045).
Regarding claim 36, Ortiz discloses a surgical tool (Fig. 1, item 10), comprising:
an end effector (Fig. 2, item 20) movable between an open configuration (Para. 0032) and a closed configuration (Para. 0032), wherein the end effector comprises:
an elongate channel (Fig. 2, item 40), wherein a cavity (Fig. 4, cavity is interior of channel 40) is defined in the elongate channel; and
an anvil (Fig. 2, item 42);
a firing beam (Fig. 4, item 226, 66, 170, 165, 166, 172, 176) movable through the end effector during a staple firing motion (Para. 0044-0049, staple firing motion can be when sled is properly placed in the cartridge or when the sled is not located in the cartridge), wherein the firing beam comprises:
a web (Fig. 11, item 165);
a first cam (Fig. 11, item 170) extending from the web, wherein the first cam is positioned (Fig. 11) and structured to engage the elongate channel (Para. 0040);
a second cam (Fig. 11, item 166) extending from the web, wherein the second cam is positioned (Fig. 11) and structured to engage the anvil (Para. 0040); and
an arm (Fig. 8, item 226) mounted to the firing beam (Fig. 8, lockout 226 is mounted to firing beam because it is attached to the firing beam), wherein the arm is movable longitudinally with the firing beam during the staple firing motion (Para. 0044-0049, lockout 226 moves as firing beam tries to moves in staple firing motion if the sled is not properly located in cartridge), and wherein at least a portion of the arm is selectively rotatable into the cavity (Para. 0044-0049).
Regarding claim 37, Ortiz discloses the surgical tool of claim 36, wherein the arm is selectively pivotable relative to the firing beam about a pivot (Fig. 8, item 232) (Para. 0044).
Regarding claim 38, Ortiz discloses the surgical tool of claim 37, wherein the pivot comprises a fixed pivot (Fig. 8, item 232) (Para. 0044).
Regarding claim 39, Ortiz discloses the surgical tool of claim 36, wherein the cavity comprises an end wall (Fig. 8, item 40) (Para. 0045), and wherein the end wall exerts a force (Para. 0045) on the arm when at least the portion of the arm is positioned in the cavity (Para. 0045) and the firing beam is being advanced distally (Para. 0045).
Regarding claim 40, Ortiz discloses the surgical tool of claim 37, wherein the firing beam further comprises a knife (Fig. 8, item 176).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 29 and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ortiz in view of Shelton et al (US 2008/0308603), hereinafter Shelton.
Regarding claim 29, Ortiz is silent about the surgical tool of claim 21, wherein the firing beam further defines an internally-threaded longitudinal bore.
However, Shelton teaches a firing beam further defines an internally-threaded longitudinal bore (Shelton, Para. 0206).
It would have been obvious to a person of ordinary skill in the art at the time the invention was made having the teachings of Ortiz and Shelton to modify the surgical tool of Ortiz to include the internally-threaded bore of Shelton. A person of ordinary skill in the art would have been motivated to make such change in order to effectively and efficiently pivot the anvil to a closed position (Shelton, Para. 0206).
Regarding claim 35, Ortiz discloses the surgical tool of claim 31, wherein the actuator further comprises a distal wedge (Fig. 4, item 180).
Ortiz is silent about the actuator comprises an internally-threaded longitudinal bore.
However, Shelton teaches a firing beam further defines an internally-threaded longitudinal bore (Shelton, Para. 0206).
It would have been obvious to a person of ordinary skill in the art at the time the invention was made having the teachings of Ortiz and Shelton to modify the surgical tool of Ortiz to include the internally-threaded bore of Shelton. A person of ordinary skill in the art would have been motivated to make such change in order to effectively and efficiently pivot the anvil to a closed position (Shelton, Para. 0206).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERONICA MARTIN whose telephone number is (571)272-3541. The examiner can normally be reached Monday-Thursday 8:00-6:00.
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/VERONICA MARTIN/Primary Examiner, Art Unit 3731