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 .
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement(s) (IDS), filed 30 April 2025, which have been placed of record in the file. An initialed, signed, and dated copy of each PTO-1449 or PTO-SB-08 form is attached to the Office action.
The listing of patents on page 1 of the IDS filed 30 April 2025 does not comply with 37 CFR 1.98(b)(3). It is noted that (1) Each U.S. patent listed in an information disclosure statement must be identified by the inventor, patent number, and issue date, has not been properly provided. The citations on page 1 have been lined through.
It is also noted that the citations on page 1 also appear on page 3 of the IDS filed 30 April 2025. Applicant will note that page 3 of the IDS has been marked as considered, and the IDS document has been signed and dated by the examiner.
Response to Preliminary Amendment
Receipt is acknowledged of a preliminary amendment, filed 22 April 2025, which has been placed of record and entered in the file.
Status of the claims:
Claims 21-40 are pending.
Claims 21-40 are new.
Claims 1-20 are canceled.
Specification and Drawings:
Amendments to the specification and drawings have not been submitted in the amendment filed 22 April 2025.
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 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.
Claim 21 is ambiguous as the phrase “each of the first pocket, the second pocket, and the second pocket” is unclear since “second pocket” is repeated in the phrase. It appears that the second occurrence of “second” should be changed to --third--.
Claim 23 is ambiguous at line 3, as it appears that the phrase “oblique to longitudinal body axis” is missing an article.
Claim 30 recites the limitation "the proximal-most staple forming pockets" in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 is ambiguous as the phrase “each of the first pocket, the second pocket, and the second pocket” is unclear since “second pocket” is repeated in the phrase. It appears that the second occurrence of “second” should be changed to --third--.
Clarification and/or correction is required.
Claims 22, 24-29, 31-36, and 38-40 depend from claims 21, 30, and 37, and are likewise rejected.
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.
Claims 21-29 and 37-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al. (US Patent Publ. No. 2018/0168633).
With respect to claim 21, Shelton et al. disclose a surgical stapler comprising an anvil 1130 (fig. 4) comprising an anvil body defining a tissue contact surface ([0369]), an elongate slot extending through the tissue contact surface (anvil slot 3904, fig. 36) and a plurality of staple forming pockets disposed in the tissue contact surface and configured to form surgical staples (staple forming pockets 3906, fig. 36), and a tissue stop extending away from the tissue contact surface and having a distally-facing stop surface configured to block tissue from sliding proximally beyond a proximal end of the tissue contact surface (tissue stop 1131 defining a proximal most tissue plane PA which prevents tissue from being positioned too far proximal, figs. 4, 7, [0370]), wherein each of the first pocket, the second pocket, and the third pocket is wholly positioned proximal to the distally-facing stop surface. Shelton et al. disclose that the proximal pattern 3022 of staples is proximal to the plane PA (fig. 7, [0370]), that staple cavities in the proximal pattern may be nonparallel to the knife slot ([0375]), that staple cavities 4710c, 4710a, 4710b and staples form the proximal pattern 4722 (fig. 25, [0386]), and that the arrangement and angular orientation of each staple cavity matches the arrangement and angular orientation of the respective staple forming pocket ([0442]); therefore Shelton et al. is considered to disclose that each of the first pocket, the second pocket, and the third pocket is wholly positioned proximal to the distally-facing stop surface.
Shelton et al. disclose a fastener cartridge 4700 (fig. 25) comprising a deck 4702 and a longitudinal slot 4704, staple cavities defined in the deck comprising a first staple cavity arranged on a first side of the slot and extending longitudinally along a first axis (cavity 4710c, fig. 25, [0386]), a second staple cavity arranged on the first side of the slot laterally outwardly of the first cavity and extending longitudinally along a second axis oblique to the first axis (cavity 4710b, fig. 25, [0386]), and a third staple cavity arranged on the first side of the slot laterally outwardly of the second cavity and extending longitudinally along a third axis oblique to at least one of the first axis or the second axis (cavity 4710a, fig. 25, [0386]). Since Shelton et al. disclose that the pockets in the anvil correspond to the cavities in the cartridge (the arrangement and angular orientation of each staple cavity matches the arrangement and angular orientation of the respective staple forming pocket, ([0442]), then the Shelton et al. anvil also includes a first pocket arranged on a first side of the slot and extending longitudinally along a first pocket axis, a second pocket arranged on the first side of the slot laterally outwardly of the first pocket and extending longitudinally along a second pocket axis oblique to the first pocket axis, and a third pocket arranged on the first side of the slot laterally outwardly of the second pocket and extending longitudinally along a third pocket axis oblique to at least one of the first pocket axis or the second pocket axis.
With respect to claim 22, Shelton et al. disclose the elongate slot extends along a longitudinal body axis of the anvil body (figs. 4, 36).
With respect to claim 23, Shelton et al. disclose one of the first pocket axis or the second pocket axis is parallel to the longitudinal body axis (the first pocket axis corresponding to cavity 4710c is parallel to the longitudinal axis LA, fig. 25), wherein the other of the first pocket axis or the second pocket axis is oblique to longitudinal body axis (the second pocket axis corresponding to cavity 4710b is oblique to the longitudinal axis LA, fig. 25).
With respect to claim 24, Shelton et al. disclose the first pocket axis is parallel to the longitudinal body axis (the first pocket axis corresponding to cavity 4710c is parallel to the longitudinal axis LA, fig. 25) and the second pocket axis is oblique to each of the first pocket axis and the longitudinal body axis (the second pocket axis corresponding to cavity 4710b is oblique to the first pocket axis and the longitudinal axis LA, fig. 25).
With respect to claim 25, Shelton et al. disclose the third pocket axis is oblique to the second pocket axis (third pocket axis corresponding to cavity 4710a is oblique to the second pocket axis corresponding to cavity 4710b, fig. 25).
With respect to claim 26, Shelton et al. disclose the third pocket axis is oblique to the first pocket axis and the second pocket axis (third pocket axis corresponding to cavity 4710a is oblique to the first pocket axis corresponding to cavity 4710c and to the second pocket axis corresponding to cavity 4710b, fig. 25).
With respect to claim 27, Shelton et al. disclose the second pocket axis is oblique to the first pocket axis by a first oblique angle, wherein the third pocket axis is oblique to the second pocket axis by a second oblique angle greater than the first oblique angle (measured from the proximal end, the third pocket axis appears to be about 135 degrees, and the second pocket axis appears to be about 45 degrees, fig. 25).
With respect to claim 28, Shelton et al. disclose each of the first pocket, the second pocket, and the third pocket includes a pair of pocket cups that cooperate to define the respective first pocket axis, second pocket axis, or third pocket axis, wherein each of the pocket cups is configured to receive and form a respective leg of a respective surgical staple (each pocket includes a pair of pocket cups defining the axis of the pocket and configured to receive a staple leg (fig. 32, [0463]).
With respect to claim 29, Shelton et al. disclose a surgical stapler (fig. 1) comprising: (a) a body (shaft mounting portion 1300, fig. 1); (b) a shaft extending away from the body (shaft assembly 1400, fig. 1); and (c) an end effector operatively coupled with the shaft (end effector 1100, fig. 1), wherein the end effector includes:(i) a first jaw comprising the surgical stapler anvil (anvil 1130, fig. 4) and (ii) a second jaw (elongate channel 1102, fig. 4), wherein the first and second jaws are configured to cooperate to clamp and staple tissue with a plurality of surgical staples (figs. 1, 4).
With respect to claim 37, Shelton et al. disclose a surgical stapler comprising an anvil 1130 (fig. 4) comprising an anvil body defining a tissue contact surface ([0369]), an elongate slot extending through the tissue contact surface (anvil slot 3904, fig. 36) along a longitudinal body axis of the anvil body (longitudinal axis LA, fig. 25), and a plurality of staple forming pockets disposed in the tissue contact surface and configured to form surgical staples (staple forming pockets 3906, fig. 36), and a tissue stop extending away from the tissue contact surface and having a distally-facing stop surface configured to block tissue from sliding proximally beyond a proximal end of the tissue contact surface (tissue stop 1131 defining a proximal most tissue plane PA which prevents tissue from being positioned too far proximal, figs. 4, 7, [0370]), wherein each of the first pocket, the second pocket, and the third pocket is wholly positioned proximal to the distally-facing stop surface. Shelton et al. disclose that the proximal pattern 3022 of staples is proximal to the plane PA (fig. 7, [0370]), that staple cavities in the proximal pattern may be nonparallel to the knife slot ([0375]), that staple cavities 4710c, 4710a, 4710b and staples form the proximal pattern 4722 (fig. 25, [0386]), and that the arrangement and angular orientation of each staple cavity matches the arrangement and angular orientation of the respective staple forming pocket ([0442]); therefore Shelton et al. is considered to disclose that each of the first pocket, the second pocket, and the third pocket is wholly positioned proximal to the distally-facing stop surface.
Shelton et al. disclose a fastener cartridge 4700 (fig. 25) comprising a deck 4702 and a longitudinal slot 4704, staple cavities defined in the deck comprising a first staple cavity arranged on a first side of the slot and extending longitudinally along a first axis that is parallel to the longitudinal body axis (cavity 4710c, fig. 25, [0386]), a second staple cavity arranged on the first side of the slot laterally outwardly of the first cavity and extending longitudinally along a second axis oblique to the longitudinal axis (cavity 4710b, fig. 25, [0386]), and a third staple cavity arranged on the first side of the slot laterally outwardly of the second cavity and extending longitudinally along a third axis oblique to the longitudinal axis (cavity 4710a, fig. 25, [0386]). Since Shelton et al. disclose that the pockets in the anvil correspond to the cavities in the cartridge (the arrangement and angular orientation of each staple cavity matches the arrangement and angular orientation of the respective staple forming pocket, ([0442]), then the Shelton et al. anvil also includes a first pocket arranged on a first side of the slot and extending longitudinally along a first pocket axis that is parallel to the longitudinal body axis, a second pocket arranged on the first side of the slot laterally outwardly of the first pocket and extending longitudinally along a second pocket axis oblique to the longitudinal body axis, and a third pocket arranged on the first side of the slot laterally outwardly of the second pocket and extending longitudinally along a third pocket axis oblique to longitudinal body axis.
With respect to claim 38, Shelton et al. disclose the third pocket axis is oblique to the first pocket axis and the second pocket axis (third pocket axis corresponding to cavity 4710a is oblique to the first pocket axis corresponding to cavity 4710c and to the second pocket axis corresponding to cavity 4710b, fig. 25).
With respect to claim 39, Shelton et al. disclose the second pocket axis is oblique to the first pocket axis by a first oblique angle, wherein the third pocket axis is oblique to the second pocket axis by a second oblique angle greater than the first oblique angle (measured from the proximal end, the third pocket axis appears to be about 135 degrees, and the second pocket axis appears to be about 45 degrees, fig. 25).
With respect to claim 40, Shelton et al. disclose each of the first pocket, the second pocket, and the third pocket includes a pair of pocket cups that cooperate to define the respective first pocket axis, second pocket axis, or third pocket axis, wherein each of the pocket cups is configured to receive and form a respective leg of a respective surgical staple (each pocket includes a pair of pocket cups defining the axis of the pocket and configured to receive a staple leg (fig. 32, [0463]).
Allowable Subject Matter
Claims 30-36 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for the indication of allowable subject matter.
Regarding independent claim 30: the subject matter of claim 30 is allowable over the prior art because of the combination of structural limitations and their functional relationship to one another. Claim 30 includes the following limitations which in combination with the other limitations of the claim are not taught or suggested by the prior art:
“(c) a plurality of staple forming pockets disposed in the tissue contact surface and configured to form surgical staples, including:
(i) an array of first pockets arranged on a first side of the elongate slot, wherein each first pocket extends longitudinally along a respective first pocket axis;
(ii) an array of second pockets arranged on the first side of the elongate slot laterally outwardly of the array of first pockets, wherein each second pocket extends longitudinally along a respective second pocket axis that is oblique to the first pocket axis of an adjacent first pocket, and
(iii) an array of third pockets arranged on the first side of the elongate slot laterally outwardly of the array of second pockets, wherein each third pocket extends longitudinally along a respective third pocket axis that is oblique to at least one a first pocket axis of an adjacent first pocket or a second pocket axis of an adjacent second pocket; and
(d) a tissue stop extending away from the tissue contact surface and having a distally-facing stop surface configured to block tissue from sliding proximally beyond a proximal end of the tissue contact surface, wherein the proximal-most staple forming pockets of each of the first array, the second array, and the third array are wholly positioned proximal to the distally-facing stop surface.”
Shelton et al. (US Patent Publ. No. 2018/0168633) is considered to be the closest prior art. Shelton et al. disclose a surgical stapling assembly comprising a first jaw and a second jaw, a fastener cartridge comprising a deck extending distally along a longitudinal axis and defining a slot, staple cavities defined in the deck, an anvil, staple pockets defined in the anvil, including a first pocket extending along an axis, a second pocket laterally outward of the first pocket and oblique to the first pocket, a third pocket laterally outward of the second pocket and oblique to the first and second pockets, and a tissue stop, in which the first pocket, the second pocket, and the third pocket are wholly positioned proximal to the distally facing stop surface of the tissue stop.
The difference between the claimed subject matter and Shelton et al., is that Shelton et al. do not disclose “(c) a plurality of staple forming pockets disposed in the tissue contact surface and configured to form surgical staples, including:(i) an array of first pockets arranged on a first side of the elongate slot, wherein each first pocket extends longitudinally along a respective first pocket axis;(ii) an array of second pockets arranged on the first side of the elongate slot laterally outwardly of the array of first pockets, wherein each second pocket extends longitudinally along a respective second pocket axis that is oblique to the first pocket axis of an adjacent first pocket, and(iii) an array of third pockets arranged on the first side of the elongate slot laterally outwardly of the array of second pockets, wherein each third pocket extends longitudinally along a respective third pocket axis that is oblique to at least one a first pocket axis of an adjacent first pocket or a second pocket axis of an adjacent second pocket; and(d) a tissue stop extending away from the tissue contact surface and having a distally-facing stop surface configured to block tissue from sliding proximally beyond a proximal end of the tissue contact surface, wherein the proximal-most staple forming pockets of each of the first array, the second array, and the third array are wholly positioned proximal to the distally-facing stop surface”.
The difference between the claimed subject matter and Shelton et al. would not have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, since such modifications to the Shelton et al. structure would have gone beyond mere substitution or incorporation of a known structure capable of achieving predictable results. Any modification to the Shelton et al. structure to arrive at the claimed subject matter would have required a reworking of the structure and the principle of operation in a manner which would not have been apparent to a person having ordinary skill in the relevant art, and would have required the improper benefit of the teachings of Applicant’s disclosure.
Claims 31-36 depend from claim 30, and would likewise be allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shelton et al. (US Patent Publ. No. 2019/0000462) disclose staple cavities and pockets proximal to a tissue stop (fig. 25).
Vadali et al. (US Patent Publ. No. 2021/0275175) disclose staple cavities proximal to a tissue stop.
Harris et al. (US Patent No. 10,675,026) disclose multiple staple cavities proximal to a tissue stop (fig. 47).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/LINDA J. HODGE/Examiner, Art Unit 3731