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 .
Application Status
This action is responsive to the claims filed 22 September 2025.
Claims 1-20 are currently pending and being examined.
Claim Objections
Claim 5 and their dependents objected to because of the following informalities: Claim 5 line 3 recites “distal movement”, should read “the distal movement”.Appropriate correction is required.
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.
Claim 6 is 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.
Claim 6 recites “the distal movement of the first shaft relative to the second shaft causes the first and second stapling heads to move toward one another along a substantially perpendicular path”, it is unclear what the path is substantially perpendicular to? Examiner will interpret as “substantially perpendicular path relative to the longitudinal axis”.
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.
Claim(s) 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Green (US 5,358,506).
Green teaches:
Claim 12: A medical device (118-figs.5-6), comprising:
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a first shaft (154-fig.6) extending from a proximal end (annotated fig.6) toward a distal end (annotated fig.6) along a longitudinal axis (annotated fig.6), wherein the first shaft defines a lumen extending from the proximal end toward the distal end (see fig.7 showing 154 defining a lumen);
a second shaft (at least 164,132,166,134-fig.7) positioned within the lumen of the first shaft (see fig.9 showing 164,132,166,134 located within 154) and comprising a distal portion extending beyond a distal end of the first shaft in at least some configurations of the medical device (Green: see fig.6 showing portion 132 extends beyond the distal end of 154);
a first stapling head (126,124-fig.5); and
a second stapling head (130-fig.5);
wherein distal movement of the first shaft relative to the second shaft causes the first stapling head to move toward the second stapling head (8:17-42).
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) 1-11 and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Green (US 5,358,506) in view of Shelton (US 2012/0138660).
Green teaches:
Claim 1: A medical device (118-figs.5-6), comprising:
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a first shaft (154-fig.6) extending from a proximal end (annotated fig.6) toward a distal end (annotated fig.6) along a longitudinal axis (annotated fig.6), wherein the first shaft defines a lumen extending from the proximal end toward the distal end (see fig.7 showing 154 defining a lumen);
a second shaft (at least 164,132,166,134-fig.7) disposed within the lumen of the first shaft (see fig.9 showing 164,132,166,134 located within 154);
a first stapling head (126,124-fig.5) and a second stapling head (130-fig.5) disposed at a distal portion of the second shaft (see annotated fig.6 showing 130,126,124 located at the distal end), wherein distal movement of the first shaft relative to the second shaft causes the first and second stapling heads to move toward one another (8:17-42); and
configured to deploy one or more staples from the first stapling head (8:30-33).
Green does not expressly teach a pushing element extending through the lumen, wherein distal movement of the pushing element along the longitudinal axis is configured to deploy one or more staples from the first stapling head.
However, Shelton teaches a pushing element (14-fig.18) extending through the lumen (32-fig.18), wherein distal movement of the pushing element along the longitudinal axis is configured to deploy one or more staples from the first stapling head (¶[0209]).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the device of Green, by the pushing element, as taught by Shelton, as a well-known and conventional means of firing staples sequentially in surgical staplers.
Green as modified by Shelton teaches:
Claim 2: The medical device of claim 1, wherein the second shaft (Green: at least 164,132,166,134-fig.7) includes a distal end configured to extend beyond a distal end of the first shaft in at least some configurations of the medical device (Green: see fig.6 showing portion 132 extends beyond the distal end of 154).
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Claim 3: The medical device of claim 1, wherein the first (Green: 130-fig.5) and second stapling heads (Green: 124,126-fig.5) are positioned on a first support (Green: annotated fig.5) and a second support (Green: annotated fig.5), respectively.
Claim 4: The medical device of claim 3, wherein the first support and the second support extend distally and radially outward relative to the longitudinal axis (Green: see annotated fig.5 showing the supports extend distally and radially outward from the axis).
Claim 5: The medical device of claim 4, wherein the first support and the second support are configured to direct the stapling heads along radially inward paths in response to distal movement of the first shaft relative to the second shaft (Green: 7:49-8:16).
Claim 6: The medical device of claim 1, wherein the distal movement of the first shaft relative to the second shaft causes the first and second stapling heads to move toward one another along a substantially perpendicular path (Green: 7:49-8:16; see figs.12-14 showing a substantially perpendicular movement path along A).
Claim 7: The medical device of claim 5, wherein the first and second supports are biased to return to a radially outward configuration when the first shaft is retracted proximally relative to the second shaft (Green: 8:34-42).
Claim 8: The medical device of claim 7, wherein the second shaft (Green: at least 164,132,166,134-fig.7) comprises a rigid elongate member (Green: 7:49-8:33), and the first shaft (Green: 154-fig.7) is axially slidable relative to the second shaft (Green: 8:17-33).
Claim 9: The medical device of claim 1, wherein the second stapling head (Green: 130-fig.5) includes a planar face configured to act as an anvil to bend the one or more staples into tissue upon contact (Green: 7:49-8:2), wherein the pushing element (Shelton: 14-fig.18) is configured to actuate a block (Shelton: 400-fig.23) disposed within the first stapling head (Shelton: ¶[0234]-[0238]), the block being configured to drive the one or more staples toward the second stapling head (Shelton: ¶[0234]-[0238]).
Claim 10: The medical device of claim 9, wherein the planar face is oriented in a plane substantially perpendicular to a trajectory of the one or more staples during deployment (Green: 8:17-42).
Claim 11: The medical device of claim 1, wherein when the first shaft is in a first position relative to the second shaft, the first stapling head and the second stapling head are spaced apart by a first distance (Green: fig.7), and wherein when the first shaft is in a second position relative to the second shaft, wherein the first and second stapling heads are spaced apart by a second distance that is less than the first distance (Green: fig.9).
Green teaches:
Claim 13. The medical device of claim 12.
Green does not expressly teach a pushing element extending through the lumen, wherein the pushing element extends through the first stapling head to drive one or more staples toward the second stapling head.
However, Shelton teaches a pushing element (14-fig.18) extending through the lumen, (32-fig.18) wherein the pushing element extends through the first stapling head to drive one or more staples toward the second stapling head (¶[0209]).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the device of Green, by the pushing element, as taught by Shelton, as a well-known and conventional means of firing staples sequentially in surgical staplers.
Green as modified by Shelton teaches:
Claim 14: The medical device of claim 13, wherein distal movement of the pushing element along the longitudinal axis is configured to deploy the one or more staples in a direction substantially perpendicular to the longitudinal axis (Shelton: ¶[0209], [0234]-[0238]).
Claim 15: The medical device of claim 12, wherein the distal movement of the first shaft relative to the second shaft causes the second stapling head to move toward the first stapling head (Green: 7:49-8:16).
Claim 16: The medical device of claim 12, wherein the distal movement of the first shaft relative to the second shaft causes the first stapling head to move substantially perpendicularly to the longitudinal axis (Green: 7:49-8:16; see figs.12-14 showing a substantially perpendicular movement path along A.
Green teaches:
Claim 17: A medical device (118-figs.5-6), comprising:
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a first shaft (154-fig.6) extending from a proximal end (annotated fig.6) toward a distal end (annotated fig.6) along a longitudinal axis (annotated fig.6), wherein the first shaft defines a lumen extending from the proximal end toward the distal end (see fig.7 showing 154 defining a lumen);
a first stapling head (126,124-fig.5) and a second stapling head (130-fig.5) disposed at a distal portion of the second shaft (see annotated fig.6 showing 130,126,124 located at the distal end), and
wherein distal movement of the first shaft relative to the second shaft causes the first stapling head to move toward the second stapling head (8:17-42).
Green does not expressly teach the first stapling head includes a movable block; a pushing element extending through the lumen of the first shaft and into the first stapling head, and wherein the pushing element is configured to drive the block of the first stapling head distally to expel one or more staples from the first stapling head.
However, Shelton teaches a first stapling head (300-fig.18) includes a movable block (400-fig.23); a pushing element (14-fig.18) extending through the lumen of the first shaft and into the first stapling head (¶[0209]), and wherein the pushing element is configured to drive the block of the first stapling head distally to expel one or more staples from the first stapling head (¶[0234]-[0238]).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the device of Green, by the pushing element, as taught by Shelton, as a well-known and conventional means of firing staples sequentially in surgical staplers.
Green as modified by Shelton teaches:
Claim 18: The medical device of claim 17, wherein the distal movement of the first shaft relative to the second shaft causes the second stapling head to move toward the first stapling head (Green: 7:49-8:16).
Claim 19: The medical device of claim 17, wherein the distal movement of the first shaft relative to the second shaft causes the first stapling head to move substantially perpendicularly to the longitudinal axis (Green: 7:49-8:16; see figs.12-14 showing a substantially perpendicular movement path along A).
Claim 20: The medical device of claim 17, wherein the second shaft (Green: at least 164,132,166,134-fig.7) includes a distal end configured to extend beyond a distal end of the first shaft in at least some configurations of the medical device (Green: see fig.6 showing portion 132 extends beyond the distal end of 154).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATIE L GERTH whose telephone number is (303)297-4602. The examiner can normally be reached Monday-Thursday 9am-4pm (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached at (571)272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATIE L GERTH/Examiner, Art Unit 3731
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