Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of species VII shown in figure 27a in the reply filed on 7/16/2026 is acknowledged.
Claim Rejections - 35 USC § 112
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 1-27 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.
Claims 1, 10, and 19 recite the limitation “the staples”. There is insufficient antecedent basis for this limitation in the claims, because claims 1, 10, and 19 recite “a plurality of staples” and it is unclear if “the staples” includes all of “a plurality of staples” or some of “a plurality of staples”. For examination purposes, “the staples” is being interpreted as “the plurality of staples”. Additionally, “nominally parallel” and “nominally the same” are indefinite because it is unclear how parallel or the same the feature must be in order to satisfy the limitations of “nominally parallel” and “nominally the same” and the specification does not define “nominally”. For examination purposes, “nominally parallel” and “nominally the same” is being interpreted as “substantially parallel” and “substantially the same”.
Claim 2 recites “the first and third surfaces being comprised thereby” it is unclear the metes and bounds of the term thereby. For examination purposes, “the first and third surfaces being comprised thereby” is being interpreted as “the first and third surfaces are near each other”.
Claim 5 recites the limitation "the external force" in line 2. There is insufficient antecedent basis for this limitation in the claim, because claim 4 recites “a force external to the tip”.
Claim 14 recites the limitation "the external force" in line 2. There is insufficient antecedent basis for this limitation in the claim, because claim 13 recites “a force external to the tip”.
Claim 23 recites the limitation "the external force" in line 2. There is insufficient antecedent basis for this limitation in the claim, because claim 22 recites “a force external to the tip”.
Claims 4-5,13-14,22-23 require the limitation of and “external force” or a “force external” this limitation is indefinite because it is unclear how an external force can be applied by movement of the first or second jaws which are internal to the apparatus.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3,10-12, and 19-21 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Scirica et al US 2008/0269793 (hereinafter Scirica).
Regarding claim 1, Scirica discloses an apparatus comprising:
(a) a first jaw (cartridge jaw 836) having a first surface including plurality of staple apertures (figs 13a-13f) that house a plurality of staples (par 0131-0135);
(b) a second jaw (anvil jaw 834) having a second surface including a plurality of staple forming pockets configured to form the staples (elongated flat section of anvil surface 834; fig.13a), wherein the first and second jaws are configured to transition from an open state (13b) to a closed state (13a) to clamp and staple tissue with the staples, wherein at least the second surface extends distally beyond the first surface (proximal portion 840 extends distally beyond the cartridge jaw first surface) and, when in the closed state with no tissue clamped therebetween, the first surface faces the second surface and is nominally parallel thereto (fig 13a);
(c) a tip (814) coupled with the second jaw (834) at the distal end of the second surface (840) such that a proximal end of the tip is longitudinally constrained relative to the second jaw, the tip comprising a body extending from the proximal end to a distal end at a first angle (par 0133); and
(d) the first jaw (836) includes a distal end having a third surface (guide surface 836a; figs 13a,b) which extends distally from a distal end of the first surface of the first jaw and at a second angle therefrom (par 0135), the first and second angles being nominally the same such that when in the closed state with no tissue clamped therebetween, a bottom surface of the body of the tip is nominally parallel to the third surface (figs 13a-13f; par 0133-0135).
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Regarding claim 2, Scirica discloses the apparatus of claim 1, wherein the first jaw comprises a staple cartridge (836; cartridge jaw), the first and third surfaces being comprised thereby (the first surface is the flat tissue contacting surface of the staple cartridge, while the third surface 836a is shown as the nose of the cartridge jaw which extends at an angle at the distal end of the cartridge jaw in figures 13a,b; par 0135).
Regarding claim 3, Scirica discloses the apparatus of claim 1, wherein, when in the closed state with no tissue clamped therebetween, a bottom surface of the body does not contact the third surface (gap 850 is shown in fig. 13f; par 0135 which shows a gap between the bottom surface of tip 814 and third surface 836a).
Regarding claim 10, Scirica discloses a surgical instrument comprising a handle, a shaft having a proximal end coupled with handle and a distal end coupled with an end effector, the end effector comprising:
(a) a first jaw (cartridge jaw 836) having a first surface (figs 13a-13f) including plurality of staple apertures that house a plurality of staples (par 0131-0135);
(b) a second jaw (anvil jaw 834) having a second surface including a plurality of staple forming pockets configured to form the staples (elongated flat section of anvil surface 834; fig.13a), wherein the first and second jaws are configured to transition from an open state (fig.13b)to a closed state (fig.13a) to clamp and staple tissue with the staples (par 0131-0133), wherein at least the second surface extends distally beyond the first surface (proximal portion 840 extends distally beyond the cartridge jaw first surface) and, when in the closed state with no tissue clamped therebetween, the first surface faces the second surface and is nominally parallel thereto (fig.13a);
(c) a tip (814) coupled with the second jaw (834) at the distal end of the second surface (840) such that a proximal end of the tip is longitudinally constrained relative to the second jaw, the tip comprising a body extending from the proximal end to a distal end at a first angle (par 0133); and
(d) the first jaw (836) includes a distal end having a third surface (guide surface 836a; figs 13a,b) which extends distally from a distal end of the first surface of the first jaw and at a second angle therefrom (par 0135), the first and second angles being nominally the same such that when in the closed state with no tissue clamped therebetween, a bottom surface of the body of the tip is nominally parallel to the third surface (figs 13a-13f; par 0133-0135).
Regarding claim 11, Scirica discloses the surgical instrument of claim 10, wherein the first jaw comprises a staple cartridge, the first and third surfaces being comprised thereby (the first surface is the flat tissue contacting surface of the staple cartridge, while the third surface 836a is shown as the nose of the cartridge jaw which extends at an angle at the distal end of the cartridge jaw in figures 13a,b; par 0135).
Regarding claim 12, Scirica discloses the surgical instrument of claim 10, wherein, when in the closed state with no tissue clamped therebetween, a bottom surface of the body does not contact the third surface (gap 850 is shown in fig. 13f; par 0135 which shows a gap between the bottom surface of tip 814 and third surface 836a).
Regarding claim 19, Scirica discloses an end effector for use with a handle or robotic am (par 0009), the end effector comprising:
(a) a first jaw (cartridge jaw 834) having a first surface including plurality of staple apertures that house a plurality of staples (elongated flat section of anvil surface 834; fig.13a);
(b) a second jaw (anvil jaw 834) having a second surface including a plurality of staple forming pockets configured to form the staples (elongated flat section of anvil surface 834; fig.13a), wherein the first and second jaws are configured to transition from an open state (fig. 13b) to a closed state (fig.13a) to clamp and staple tissue with the staples (par 0131-0133), wherein at least the second surface extends distally beyond the first surface (proximal portion 840 extends distally beyond the cartridge jaw first surface) and, when in the closed state with no tissue clamped therebetween, the first surface faces the second surface and is nominally parallel thereto (fig.13a);
(c) a tip (814) coupled with the second jaw (834) at the distal end of the second surface (840) such that a proximal end of the tip is longitudinally constrained relative to the second jaw, the tip comprising a body extending from the proximal end to a distal end at a first angle (par 0133); and
(d) the first jaw (836) includes a distal end having a third surface (guide surface 836a; figs 13a,b) which extends distally from a distal end of the first surface of the first jaw and at a second angle therefrom (par 0135), the first and second angles being nominally the same such that when in the closed state with no tissue clamped therebetween, a bottom surface of the body of the tip is nominally parallel to the third surface (figs 13a-13f; par 0133-0135).
Regarding claim 20, Scirica discloses the end effector of claim 19, wherein the first jaw comprises a staple cartridge, the first and third surfaces being comprised thereby (the first surface is the flat tissue contacting surface of the staple cartridge, while the third surface 836a is shown as the nose of the cartridge jaw which extends at an angle at the distal end of the cartridge jaw in figures 13a,b; par 0135).
Regarding claim 21, Scirica discloses the end effector of claim 19, wherein, when in the closed state with no tissue clamped therebetween, a bottom surface of the body does not contact the third surface (gap 850 is shown in fig. 13f; par 0135 which shows a gap between the bottom surface of tip 814 and third surface 836a).
Claim Rejections - 35 USC § 103
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) 4-9,13-18, and 22-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scirica US 2008/0269793 in view of Smith (US 2019/0076143).
Regarding claim 4, Sirica discloses the apparatus of claim 1, wherein Scirica fails to explicitly teach the distal end of the tip is moveable from the first angle via application of a force external to the tip.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 5, Sirica discloses the apparatus of claim 4, wherein Scirica fails to explicitly teach the distal end of the tip returns to the first angle upon cessation of the application of the external force.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles and can move back to its original position when no force is acting on it because it is formed from a flexible material which can flex out of the way and move back to the first position when no force is acting on it; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 6, Sirica discloses the apparatus of claim 1, wherein Scirica fails to explicitly teach the distal end of the tip is moveable from the first angle and when in the closed state with tissue clamped therebetween and extending beyond the distal end of the second surface, the tip is deflected to a third angle different from the first angle.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, such as a first angle to a second and third angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 7, Sirica discloses the apparatus of claim 1, wherein Scirica fails to explicitly teach the body is elastically deformable.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 8, Sirica discloses the apparatus of claim 1, wherein Scirica fails to explicitly teach the tip deflects about the distal end of the second surface.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, which deflects about the distal end of the anvil jaw or second surface; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 9, Sirica discloses the apparatus of claim 1, wherein the distal end of the tip is moveable about a range of angles relative to the second jaw, including the first and third angles.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, such as a first angle to a second and third angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 13, Sirica discloses the surgical instrument of claim 10, wherein Scirica fails to explicitly teach the distal end of the tip is moveable from the first angle via application of a force external to the tip.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 14, Sirica discloses the surgical instrument of claim 13, wherein Scirica fails to explicitly teach the distal end of the tip returns to the first angle upon cessation of the application of the external force.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles and can move back to its original position when no force is acting on it because it is formed from a flexible material which can flex out of the way and move back to the first position when no force is acting on it; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 15, Sirica discloses the surgical instrument of claim 10, wherein Scirica fails to explicitly teach the distal end of the tip is moveable from the first angle and when in the closed state with tissue clamped therebetween and extending beyond the distal end of the second surface, the tip is deflected to a third angle different from the first angle.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, such as a first angle to a second and third angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 16, Sirica discloses the surgical instrument of claim 10, wherein Scirica fails to explicitly teach the body is elastically deformable.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 17, Sirica discloses the surgical instrument of claim 10, wherein Scirica fails to explicitly teach the tip deflects about the distal end of the second surface.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, which deflects about the distal end of the anvil jaw or second surface; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 18, Sirica discloses the surgical instrument of claim 10, wherein Scirica fails to explicitly teach the distal end of the tip is moveable about a range of angles relative to the second jaw, including the first and third angles.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, such as a first angle to a second and third angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 22, Sirica discloses the end effector of claim 19, wherein Scirica fails to explicitly teach the distal end of the tip is moveable from the first angle via application of a force external to the tip.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 23, Sirica discloses the end effector of claim 20, wherein Scirica fails to explicitly teach the distal end of the tip returns to the first angle upon cessation of the application of the external force.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles and can move back to its original position when no force is acting on it because it is formed from a flexible material which can flex out of the way and move back to the first position when no force is acting on it; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 24, Sirica discloses the end effector of claim 19, wherein Scirica fails to explicitly teach the distal end of the tip is moveable from the first angle and when in the closed state with tissue clamped therebetween and extending beyond the distal end of the second surface, the tip is deflected to a third angle different from the first angle.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, such as a first angle to a second and third angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 25, Sirica discloses the end effector of claim 19, wherein Scirica fails to explicitly teach the body is elastically deformable.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 26, Sirica discloses the end effector of claim 19, wherein Scirica fails to explicitly teach the tip deflects about the distal end of the second surface.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, which deflects about the distal end of the anvil jaw or second surface; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Regarding claim 27, Sirica discloses the end effector of claim 19, wherein Scirica fails to explicitly teach the distal end of the tip is moveable about a range of angles relative to the second jaw, including the first and third angles.
However Smith teaches a surgical stapling instrument with a flexible introducer tip 211 which is formed from a flexible material that flexes in response to abutting against delicate anatomical tissue interpreted as an external force which moves the tip into various angles, such as a first angle to a second and third angles; par 0038.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing to have modified the tip 814 as taught by Scirica with the flexible movement as taught by Smith by making a portion or all of the tip 814 out of a flexible resilient material, to move with and around delicate tissue during surgical operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C HIBBERT-COPELAND whose telephone number is (571)270-0601. The examiner can normally be reached M-TH 9am -5pm.
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/MARY C HIBBERT-COPELAND/Examiner, Art Unit 3731
/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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