DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed February 26, 2026.
Status of Claims
1. Claims 16-20 and 23-35 are pending and currently under consideration for patentability.
Claims 21-22 are cancelled as of the February 26, 2026 amendment.
Response to Arguments
2. Applicant's arguments filed February 26, 2026 have been fully considered but they are not persuasive. With regard to applicant’s argument that Shelton does not disclose or suggest a "multi-ply pouch" with "medicant separated into one or more layers within the multi-ply pouch" where "rupturing the multi-ply pouch mixes the medicant within the multi-ply pouch” as recited by amended claim 16, examiner respectfully disagrees. Looking to the cited paragraph [0065] of Shelton, it is noted that: “An adjunct can also be formed from a film formed from any suitable material or combination thereof discussed below. The film can include one or more layers, each of which can have different degradation rates. Furthermore, the film can have various regions formed therein, for example, reservoirs that can releasably retain therein one or more medicants in a number of different forms. The reservoirs having at least one medicant disposed therein can be sealed using one or more different coating layers which can include absorbable or non-absorbable polymers. The film can be formed in various ways, for example, it can be an extruded or a compression molded film.” While the adjunct (2006) of Shelton in Figure 8 is cited and referred to as the closest figure depicting the adjunct and multiple medicant, it is clear that Shelton provides suggestion for alternative adjunct structures throughout the disclosure, including a multi-ply pouch with medicant separated into one or more layers within the multi-ply pouch, as claimed. Looking to paragraph [0088] of Shelton, it is disclosed that: “An adjunct in accordance with the described techniques can be associated with at least one medicant in a number of different ways, so as to provide a desired effect, such as on tissue in-growth, in a desired manner. The at least one medicant can be configured to be released from the adjunct in multiple spatial and temporal patterns to trigger a desired healing process at a treatment site. The medicant can be disposed within, bonded to, incorporated within, dispersed within, or otherwise associated with the adjunct. For example, the adjunct can have one or more regions releasably retaining therein one or more different medicants. The regions can be distinct reservoirs of various sizes and shapes and retaining medicants therein in various ways, or other distinct or continuous regions within the adjuncts. In some aspects, a specific configuration of the adjunct allows it to releasably retain therein a medicant or more than one different medicant.” Accordingly, Shelton clearly suggests many forms of medicant release, and upon rupturing the multi-ply pouch, there will be an inherent point in which the medicants mix within the multi-ply pouch, as required by the claim. Also consider paragraphs [0043], [0092] and [0094] of Shelton where medicant mixing, distribution of effective amounts of one or more medicants, and drug release feature suggestions are made. Further, a “pouch” is defined as a small bag or packet, and any adjunct having two walls sealed on either side with space in between will be considered as reading on the claimed pouch. Looking to paragraphs such as [0098], Shelton makes it known that the drug delivery adjuncts may be in the form of microcontainers sealed with a plug. Accordingly, the grounds of rejection presented in the most recent Office action is maintained herein.
Claim Rejections - 35 USC § 102
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 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.
3. Claim(s) 16-20 and 23-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al. (US PGPUB 2022/0313247 A1).
4. With regard to claim 16, Shelton discloses a staple cartridge (40, 102, 2008; Figs. 1, 2, 6, 7, 8, 9; abstract; [0006]; [0045-0046]) comprising: an elongate body (best seen in Fig. 6; jaws disclosed as elongate in [0045]) comprising: a central slit (slot, 2014; best seen in Figs. 8, 9; [0012]; [0101]; [0105]); a driver (staple drivers, 48) comprising at least one of a sled (wedge sled, 47; Fig. 2) and a knife (knife blade, 36; best seen in Fig. 3; or cutting element, 2016; best seen in Fig. 9; [0045]; [0047]; [0050]), the driver (48) configured to translate through at least a portion of the central slit (2014); a deck (deck surface, 2007); a plurality of staple pockets (“the crowns of the staples can be supported by staple drivers (not shown)”; [0060]), each of the staple pockets ([0060]) accessible via an opening (staple cavities, 41) defined by the deck (2007; [0105]; best seen in Figs. 1, 8, 9); and a plurality of staples (106; Figs. 6, 7; and 2010a-c, 2012a-c; Figs. 8, 9) disposed within the plurality of staple pockets (not shown; [0060-0061]); and an implantable pouch (adjunct, 2006; Figs. 8, 9) comprising a medicant (first drug, 2026 and second drug, 2028) disposed therein ([0073-0086]; [0099-0100]; [0105-0106]), the implantable pouch (2006) being removably secured to the elongate body ([0105]) and positioned to be ruptured by at least one of: the driver (48) when it translates through at least the portion of the central slit (2014; [0050]), or at least one of the plurality of staples (106) as the at least one of the plurality of staples (106) is ejected from one of the plurality of staple pockets ([0101]; [0105]; Fig. 9), wherein rupturing of the implantable pouch (2006) releases the medicant ([0105]; [0109]), wherein the implantable pouch (2006; Figs. 8, 9) is a multi-ply pouch (one or more film layers) and the medicant (2026, 2028) is separated into one or more layers (2020a, 2022b) within the multi-ply pouch (2006; [0008]; [0013]; [0065]; [0103]; [0124]); wherein rupturing the multi-ply implantable pouch (2006) mixes the medicant (2026, 2028) separated into one or more layers within the multi-ply pouch (2006; Fig. 9; [0012]; [0043]; [0050]; [0060]; [0088]; [0095]; [0101]; [0105]; [0110]).
5. With regard to claim 27, Shelton discloses, in combination, the staple cartridge (40, 102, 2008) of claim 16 (see rejection above) and an end effector (30, 2000) of a surgical instrument (surgical stapler, 10; abstract; Figs. 1, 2, 6, 7, 8, 9; [0037-0038]; [0046-0048]), the end effector (30, 2000) comprising: a channel jaw (lower jaw, 32 having staple channel, 56); an anvil jaw (upper jaw, 34 with anvil surface, 33; Figs. 1, 2; or anvil, 2002; Figs. 8, 9), hingedly connected to the channel jaw (32), and movable between an open position and a closed position with respect to the channel jaw ([0101]; [0105]); the staple cartridge (40, 102, 2008) of claim 16 disposed in the channel jaw (32, 56; [0045-0046]).
6. With regard to claim 31, Shelton discloses a method ([0034-0035]; [0058]) for applying a medicant (2026, 2028; [0073-0086]; [0105-0106]) onto an end effector (30, 2000) of a surgical instrument (surgical stapler, 10), for delivery to a targeted tissue (abstract; Figs. 1, 2, 6, 7, 8, 9; [0037-0038]; [0046-0048]), the method comprising: assembling the end effector (30, 2000; [0049]; [0053]), the end effector (30, 3000) comprising: a channel jaw (lower jaw, 32 having staple channel, 56); an anvil jaw (upper jaw, 34 with anvil surface, 33; Figs. 1, 2; or anvil, 2002; Figs. 8, 9), hingedly connected to the channel jaw (32), and movable between an open position and a closed position with respect to the channel jaw ([0101]; [0105]); a staple cartridge (40, 102, 2008) disposed in the channel jaw (32, 56; [0045-0046]), comprising: an elongate body (best seen in Fig. 6; jaws disclosed as elongate in [0045]) comprising: a central slit (slot, 2014; best seen in Figs. 8, 9; [0012]; [0101]; [0105]); a driver (staple drivers, 48) comprising at least one of a sled (wedge sled, 47; Fig. 2) and a knife (knife blade, 36; best seen in Fig. 3; or cutting element, 2016; best seen in Fig. 9; [0045]; [0047]; [0050]), the driver (48) configured to translate through at least a portion of the central slit (2014); a deck (deck surface, 2007); a plurality of staple pockets (“the crowns of the staples can be supported by staple drivers (not shown)”; [0060]), each of the staple pockets ([0060]) accessible via an opening (staple cavities, 41) defined by the deck (2007; [0105]; best seen in Figs. 1, 8, 9); and a plurality of staples (106; Figs. 6, 7; and 2010a-c, 2012a-c; Figs. 8, 9) disposed within the plurality of staple pockets (not shown; [0060-0061]); and an implantable pouch (adjunct, 2006; Figs. 8, 9) comprising a medicant (first drug, 2026 and second drug, 2028); adhering the implantable pouch (2006), comprising the medicant (2026, 2028), to the staple cartridge (40, 102, 2008; [0061]); clamping the targeted tissue (T; [0046-0047]; [0049]) with the anvil jaw (33, 2002) while in the closed position and the implantable pouch (2006) being disposed therebetween the anvil jaw (33, 2002) and the targeted tissue (T; Figs. 7, 9; [0095]; [0101-0102]; [0105]); rupturing the implantable pouch (2006), comprising the medicant (2026, 2028) with the plurality of staples (106, 2010, 2012) while the anvil jaw (33, 2002) is in the closed position (Fig. 9; [0105]; [0108]); and delivering (“drug release”) the medicant (2026, 2028) via the plurality of staples (106, 2010, 2012) to the targeted tissue (T; [0095]; [0101]; [0110]).
7. With regard to claim 17, Shelton discloses that when the sled (47; Fig. 2) moves through the central slit (2014; best seen in Figs. 8, 9) of the staple cartridge (40, 102, 2008), the sled (47) pushes the plurality of staples (106, 2010, 2012) from the plurality of staple pockets (“the crowns of the staples can be supported by staple drivers (not shown)”; [0060]) through the openings (41) in the deck and thereby rupturing the implantable pouch (2006; [0050]; [0012]; [0095]; [0101]; [0105]; [0110]).
8. With regard to claim 18, Shelton discloses that rupturing the implantable pouch (2006) releases the medicant (2026, 2028) onto the plurality of staples (106, 2010, 2012; Figs. 7, 9; [0050]; [0012]; [0095]; [0101]; [0105]; [0110]).
9. With regard to claim 19, Shelton discloses that the driver (staple drivers, 48) ruptures the implantable pouch (2006) while moving through the staple cartridge (40, 102, 2008; [0050]; [0012]; [0060]; [0095]; [0101]; [0105]; [0110]).
10. With regard to claim 20, Shelton discloses that the driver (48) divides the implantable pouch (2006) into one or more pieces (microstructures, 2020a and 2022b; Fig. 9; [0109]) while moving through the central slit (2014) of the staple cartridge (40, 102, 2008), releasing the medicant (2026, 2028; Fig. 9; [0012]; [0050]; [0060]; [0095]; [0101]; [0105]; [0110]).
11. With regard to claims 23-26, Shelton discloses that the implantable pouch (2006) swells responsive to the medicant (2026, 2028) mixing within the implantable pouch (2006; Fig. 9; “can degrade to form a gel”; [0038]; [0073]; “hydrogels”; [0111]; [0121]); wherein the medicant (2026, 2028) of the implantable pouch (2006) contains at least one hydrophilic swellable polymer ([0073-0086]; [0105-0106]; “can degrade to form a gel”; [0038]; [0073]; “hydrogels”; [0111]; [0121]); or wherein the medicant (2026, 2028) of the implantable pouch (2006) comprises at least one of antibiotics, an anti-inflammatory medication, a hemostasis agent, anti-bacterial agents or a chemotherapy medication selected from the group consisting of alkylating agents, antimetabolites, anthracyclines, corticosteroids, and plant alkaloids ([0073-0086]; [0105-0106]).
12. With regard to claim 28, Shelton discloses that the anvil (33, 2002) upon moving to the closed position (Fig. 9) compresses the implantable pouch (2006) thereby causing the medicant (2026, 2028) to mix within the implantable pouch (2006; [0012]; [0050]; [0060]; [0095]; [0101]; [0105]; [0110]).
13. With regard to claim 29, Shelton discloses that the staple cartridge (40, 102, 2008) is configured to releasably attach and detach to at least a portion of the channel jaw (32, 56; Fig. 2; [0046-0049]).
14. With regard to claim 30, Shelton discloses that the medicant (2026, 2028) is within each of the one or more implantable pouches (2006) is selected from the group consisting of antibiotics, anti- inflammatory medications, and hemostasis agents ([0073-0086]; [0105-0106]).
15. With regard to claim 32, Shelton discloses rupturing the implantable pouch (2006; Fig. 9), comprising the medicant (2026, 2028) with the plurality of staples (104; 2010, 2012) while the anvil jaw (33, 2002) is in the closed position comprises: pushing the plurality of staples (104; 2010, 2012) from the plurality of staple pockets (“the crowns of the staples can be supported by staple drivers (not shown)”; [0060]) through the opening (41) in the deck (2007) to rupture the implantable pouch (2006; [0012]; [0050]; [0060]; [0095]; [0101]; [0105]; [0110]).
16. With regard to claim 33, Shelton discloses pushing the plurality of staples (104; 2010, 2012) from the plurality of staple pockets (“the crowns of the staples can be supported by staple drivers (not shown)”; [0060]) through the opening (41) in the deck (2007) to rupture the implantable pouch (2006) comprises coating at least a portion of the plurality of staples with medicant (2026, 2028), wherein the medicant comprises at least one of antibiotics, an anti-inflammatory medication, a hemostasis agent, anti-bacterial agents or a chemotherapy medication ([0073-0086]; [0105-0106]; [0043]; [0065]; [0090]).
17. With regard to claim 34, Shelton discloses clamping the targeted tissue (T) with the anvil jaw (33, 2002) while in the closed position and the implantable pouch (2006) being disposed therebetween the anvil jaw (33, 2002) and the targeted tissue (T; Fig. 9) comprises swelling the medicant (2026, 2028) within the implantable pouch (2006; “can degrade to form a gel”; [0038]; [0073]; “hydrogels”; [0111]; [0121]), wherein the medicant (2026, 2028) comprises at least one hydrophilic swellable polymer ([0073-0086]; [0105-0106]); configured to swell the implantable pouch (2006) when the anvil jaw (33, 2002) clamps the targeted tissue (T) with the implantable pouch (2006) disposed therebetween (Fig. 9; [0038]; [0073]; [0111]; [0121]).
18. With regard to claim 35, Shelton discloses clamping the targeted tissue (T) with the anvil jaw (33, 2002) while in the closed position and the implantable pouch (2006) being disposed therebetween the anvil jaw (33, 2002) and the targeted tissue (T; Fig. 9) comprises: mixing the medicant (2026, 2028) within the implantable pouch (2006; [0043]); and wherein the implantable pouch (2006) is a multi-ply pouch (one or more film layers) and the medicant (2026, 2028) is separated into one or more layers (2020a, 2022b) within the multi-ply pouch (2006; [0008]; [0013]; [0065]; [0103]; [0124]); wherein rupturing the multi-ply implantable pouch (2006) mixes the medicant (2026, 2028) separated into one or more layers within the multi-ply pouch when the anvil jaw clamps the targeted tissue with the implantable pouch disposed therebetween (2006; Fig. 9; [0012]; [0050]; [0060]; [0095]; [0101]; [0105]; [0110]).
Conclusion
19. 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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