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 .
DETAILED ACTION
This is in response to Application filed August 2, 2024, in which claim(s) 1-6, 8-15, and 20-25 is/are presented for examination.
Status of Claims
Claim(s) 1-6, 8-15, and 20-25 is/are pending of which Claim(s) 1, 12, and 20 is/are presented in independent form.
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection. After an updated search, Examiner has updated the rejection below resulting from Applicant’s claim amendments.
Claim Interpretation
In the interest of clarity, Examiner notes the following unconventional use of art-recognized terms in the claims:
The claims recite “cartridge” but are referring to an “end effector”, not a staple cartridge.
The claims recite “staple leg” but are referring to a “staple cartridge jaw”, not the leg of a staple.
The claims recite “anvil leg” but are referring to an “anvil jaw”; an anvil leg has no accepted meaning.
The claims recite “a leg of a surgical stapler” but are referring to “a jaw of a surgical stapler”.
Claim Rejections - 35 USC § 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1-6, 8-15 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Shankarsetty et al. US 2019/0254671 in view of Scarpone US 2021/0228331.
Regarding Claim 1, Shankarsetty teaches a cartridge (30) configured to be connected to a surgical stapler (1), comprising
an anvil leg (40) comprising an inwardly facing surface (see FIG. 3);
a staple leg (50) pivotally connected ([0037], last sentence) to the anvil leg comprising a plurality of staples (58) positioned in an interior of the staple leg and an inwardly facing surface (comprising 55) configured to move towards the inwardly facing surface of the anvil leg, the inwardly facing surface comprising a plurality of openings (55) positioned for the plurality of staples to pass through the plurality of openings to tissue positioned between the inwardly facing surface of the anvil leg and the inwardly facing surface of the staple leg ([0040]), and
a cover device (FIGS. 4-8) comprising at least one sleeve (110) attached to the inwardly facing surface of the anvil leg, the at least one sleeve comprising a proximal end (110a), a distal end (110b), and a curved surface (114) extending therebetween (see FIG. 5), wherein the at least one sleeve is configured to separate from the inwardly facing surface of the anvil leg due to forces exerted on the at least one sleeve by the plurality of staples, such that the at least one sleeve attaches to the tissue positioned between the inwardly facing surface of the anvil leg and the inwardly facing surface of the staple leg with the plurality of staples securing the at least one sleeve to the tissue (detailed in [0055]).
Shankarsetty does not specifically disclose the sleeve comprising amnion, but teaches “The surgical [sleeve is] fabricated from biocompatible materials which are bioabsorbable [], natural [] materials.” ([0042]).
With this teaching in mind, Scarpone (US 2021/0228331) discloses a sleeve using amnion ([0046], amniotic and placental membranes are considered “comprising amnion”), which is considered a biocompatible, bioabsorbable, natural material, Scarpone teaching “these types of [sleeve]-like implants can be made from placental membranes [ ] to further enhance their ability to stimulate the regeneration, repair, and/or reattachment of damaged [tissue]” ([0036]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the sleeve of Shankarsetty, by having the bioabsorbable sleeve comprise amnion, as taught by Scarpone, since Shankarsetty teaches the sleeve is fabricated from biocompatible materials which are bioabsorbable, natural materials, and Scarpone discloses natural, biocompatible amnion enhances the ability to stimulate the regeneration, repair, and/or reattachment of damaged tissue, which would improve the biocompatibility of Shankarsetty’s sleeve.
Regarding Claim 2, Scarpone further teaches wherein the at least one sleeve (110) comprises a one ply, two ply, three ply or four ply sheet of dried chorion-free amnion (at least Paras [0043 and 0049]; additionally, as chorion has not been mentioned in the disclosure of Scarpone, it is interpreted as “chorion-free” as claimed).
Regarding Claim 3, Scarpone further teaches wherein the at least one sleeve (110) comprises chorion-free amnion (as chorion has not been mentioned in the disclosure of Scarpone, it is interpreted as “chorion-free” as claimed).
Regarding Claim 4, Shankarsetty further discloses wherein the cover device (Figs. 4-8) is configured to transfer from the inwardly facing surface of the anvil leg or the stable leg to wetted tissue of a patient at a surgical site (at least Paras. [0055-0056]).
Regarding Claim 5, Shankarsetty/Scarpone disclose(s) the invention as claimed above. They do not explicitly disclose wherein the at least one sleeve comprises a sheet having a thickness of about 50um to about 100um. However, as the prior art is analogous to Applicant’s invention and used in the same general conditions, it would be obvious that finding the workable ranges by routine experimentation would be well within the capability of one having ordinary skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized the thickness as being within the general conditions of the prior art and found workable ranges through routine experimentation. See 2144, II for more information. Additionally, Applicant has not stated any specific or unexpected results from the claimed range.
Regarding Claim 6, Shankarsetty/Scarpone disclose(s) the invention as claimed above. They do not explicitly disclose wherein the at least one sleeve has a width of about 3 cm to 5 cm and a length of about 5 cm to 7 cm. However, as the prior art is analogous to Applicant’s invention and used in the same general conditions, it would be obvious that finding the workable ranges by routine experimentation would be well within the capability of one having ordinary skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized the thickness as being within the general conditions of the prior art and found workable ranges through routine experimentation. See 2144, II for more information. Additionally, Applicant has not stated any specific or unexpected results from the claimed range.
Regarding Claim 8, Shankarsetty further discloses wherein the plurality of openings (55) of the inwardly facing surface of the staple leg is arranged in a substantially linear pattern producing a stapled region that is from 1 to 3 staples in width and from 3 to 10 staples in length (at least Para. [0046]; this claimed configuration is well known in the art but reference to at least the ‘423 Pub further details that staplers of this type produce patterns as claimed).
Regarding Claim 9, Shankarsetty further discloses wherein the cartridge is configured to simultaneously release the plurality of staples (58) through the plurality of openings (55) upon triggering of the surgical stapler creating at least one staple line through the tissue (at least Paras. [005-0056]).
Regarding Claim 10, Shankarsetty further discloses wherein the cartridge (30) comprises a connector (Fig. 2) extending from a proximal end of the anvil leg (40) or the staple leg (50), the connector being configured to engage a corresponding port of a handle of the surgical stapler for connecting the cartridge to the handle (at least Figs. 1 and 4; Para. [0041)).
Regarding Claim 11, Shankarsetty further discloses wherein the surgical stapler is a gastrointestinal stapler (Paras. [0004 and 0037]; inasmuch as currently claimed the staple of Shankarsetty is disclosed for use in at least the abdominal wall).
Regarding Claim 12, Shankarsetty teaches a cover device (FIGS. 4-8) configured to be positioned on a leg (40) of a surgical stapler (1) and to transfer from the leg of the surgical stapler to tissue at a surgical site during a stapling procedure, the cover device comprising at least one sleeve (110) configured to be attached to an inwardly facing surface of the leg of the surgical stapler, the at least one sleeve comprising a proximal end (110a), a distal end (110b), and a curved surface (114) extending therebetween, wherein the at least one sleeve is configured to separate from the inwardly facing surface of the leg of the surgical stapler due to forces exerted on the at least one sleeve by a plurality of staples released by the surgical stapler, such that the at least one sleeve attaches to the tissue at the surgical site with the plurality of staples securing the at least one sleeve to the tissue (detailed in [0055]).
Shankarsetty does not specifically disclose the sleeve comprising amnion, but teaches “The surgical [sleeve is] fabricated from biocompatible materials which are bioabsorbable [], natural [] materials.” ([0042]).
With this teaching in mind, Scarpone (US 2021/0228331) discloses a sleeve using amnion ([0046], amniotic and placental membranes are considered “comprising amnion”), which is considered a biocompatible, bioabsorbable, natural material, Scarpone teaching “these types of [sleeve]-like implants can be made from placental membranes [ ] to further enhance their ability to stimulate the regeneration, repair, and/or reattachment of damaged [tissue]” ([0036]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the sleeve of Shankarsetty, by having the bioabsorbable sleeve comprise amnion, as taught by Scarpone, since Shankarsetty teaches the sleeve is fabricated from biocompatible materials which are bioabsorbable, natural materials, and Scarpone discloses natural, biocompatible amnion enhances the ability to stimulate the regeneration, repair, and/or reattachment of damaged tissue, which would improve the biocompatibility of Shankarsetty’s sleeve.
Regarding Claim 13, Scarpone further teaches wherein the at least one sleeve (110) comprises a one ply, two ply, three ply or four ply sheet of dried chorion-free amnion (at least Paras [0043 and 0049]; additionally, as chorion has not been mentioned in the disclosure of Scarpone, it is interpreted as “chorion-free” as claimed).
Regarding Claim 14, Scarpone further teaches wherein the at least one sleeve (110) comprises chorion-free amnion (as chorion has not been mentioned in the disclosure of Scarpone, it is interpreted as “chorion-free” as claimed).
Regarding Claim 15, Shankarsetty further discloses wherein the cover device (Figs. 4-8) is configured to transfer from the inwardly facing surface of the anvil leg or the stable leg to wetted tissue of a patient at a surgical site (at least Paras. [0055-0056]).
Regarding Claim 20, Shankarsetty teaches a method for performing a surgical procedure, comprising:
preparing a surgical stapler (1) comprising a cartridge (30) for the surgical procedure, wherein the cartridge comprises: an anvil leg (40) comprising an inwardly facing surface (see FIG. 3); a staple leg (50) pivotally connected ([0037], last sentence) to the anvil leg comprising a plurality of staples (58) positioned in an interior of the staple leg and an inwardly facing surface (comprising 55) configured to move towards the inwardly facing surface of the anvil leg, the inwardly facing surface comprising a plurality of openings (55) positioned for the plurality of staples to pass through the plurality of openings, and a cover device (FIGS. 4-8) comprising at least one sleeve (110) attached to the inwardly facing surface of the anvil leg, the at least one sleeve comprising a proximal end (110a), a distal end (110b), and a curved surface (114) extending therebetween (see FIG. 5);
positioning patient tissue of a surgical site between the anvil leg and the staple leg of the cartridge;
tightening the cartridge causing the staple leg to move toward the anvil leg and causing at least a portion of the curved surface of the at least one sleeve to press against the patient tissue; and
activating the surgical stapler causing the plurality of staples to pass from the staple leg through the patient tissue and the at least one sleeve, thereby causing the at least one sleeve to separate from the inwardly facing surface of at least one of the anvil leg or the staple leg due to forces exerted on the at least one sleeve by the plurality of staples and forming at least one staple line in the patient tissue that secures the at least one sleeve to the patient tissue (the positioning, tightening, and activating steps are all described in [0055]).
Shankarsetty does not specifically disclose the sleeve comprising amnion, but teaches “The surgical [sleeve is] fabricated from biocompatible materials which are bioabsorbable [], natural [] materials.” ([0042]).
With this teaching in mind, Scarpone (US 2021/0228331) discloses a sleeve using amnion ([0046], amniotic and placental membranes are considered “comprising amnion”), which is considered a biocompatible, bioabsorbable, natural material, Scarpone teaching “these types of [sleeve]-like implants can be made from placental membranes [ ] to further enhance their ability to stimulate the regeneration, repair, and/or reattachment of damaged [tissue]” ([0036]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the sleeve of Shankarsetty, by having the bioabsorbable sleeve comprise amnion, as taught by Scarpone, since Shankarsetty teaches the sleeve is fabricated from biocompatible materials which are bioabsorbable, natural materials, and Scarpone discloses natural, biocompatible amnion enhances the ability to stimulate the regeneration, repair, and/or reattachment of damaged tissue, which would improve the biocompatibility of Shankarsetty’s sleeve.
Regarding Claim 21, Shankarsetty further discloses wherein the at least one sleeve further comprises a perforated line (115) extending longitudinally through the at least one sleeve between the proximal end and the distal end of the at least one sleeve (Para. [0007] at least Fig. 5), and wherein the forces exerted on the at least one sleeve by the plurality of staples cause the at least one sleeve to separate along the perforated line, thereby separating the at least one sleeve from the inwardly facing surface of at least one of the anvil leg or the staple leg (at least Paras. [0049 and 0056]).
Regarding Claim 22, Shankarsetty/Sarcone disclose(s) the invention as claimed above. They do not explicitly disclose wherein the at least one sleeve is formed from a 5 cm by 7 cm rectangular sheet of amnion or 4 cm by 6 cm rectangular sheet of amnion. However, as the prior art is analogous to Applicant’s invention and used in the same general conditions, it would be obvious that finding the workable ranges by routine experimentation would be well within the capability of one having ordinary skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized the thickness as being within the general conditions of the prior art and found workable ranges through routine experimentation. See 2144, II for more information. Additionally, Applicant has not stated any specific or unexpected results from the claimed range.
Regarding Claim 23, Shankarsetty further discloses wherein the at least one sleeve further comprises a perforated line (115) extending longitudinally through the at least one sleeve between the proximal end and the distal end of the at least one sleeve (Para. [0007] at least Fig. 5), and wherein the forces exerted on the at least one sleeve by the plurality of staples cause the at least one sleeve to separate along the perforated line, thereby separating the at least one sleeve from the inwardly facing surface of at least one of the anvil leg or the staple leg (at least Paras. [0049 and 0056]) so that the at least one sleeve is secured to the patient tissue by the plurality of staples.
Regarding Claim 24, Shankarsetty further discloses wherein activating the surgical stapler releases the plurality of staples producing at least two parallel lines of staples (at least Paras. [0041 and 0046]; this claimed configuration is well known in the art but reference to at least the ‘139 Miliman further details that staplers of this type produce patterns as claimed).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Shankarsetty et al. US 2019/0254671 in view of Scarpone US 2021/0228331 as combined above and further in view of Harris et al. (hereinafter Harris) USPUB 2017/0055986.
Regarding Claim 25, Shankarsetty/Scarpone disclose(s) the invention as claimed above. They do not disclose wherein the surgical procedure comprises a side-to-side anastomosis, and wherein positioning patient tissue between the anvil leg and the staple leg of the cartridge comprises inserting the anvil leg and the staple leg through open ends of tubular structures of the gastrointestinal tract of the patient that are to be joined together. However, Harris teaches a method comprising a side-to-side anastomosis, and wherein positioning patient tissue between the anvil leg and the staple leg of the cartridge comprises inserting the anvil leg and the staple leg through open ends of tubular structures of the gastrointestinal tract of the patient that are to be joined together (Para. [0560]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known that the method for the surgical procedure could have included a side-to-side anastomosis as claimed; because Harris teaches that this method is known in the art and beneficial for attaching tissue in this manner.
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANNA K KINSAUL whose telephone number is (571)270-1926. The examiner can normally be reached Monday-Friday 8:30am-5pm.
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/ANNA K KINSAUL/Supervisory Patent Examiner, Art Unit 3731