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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-20) in the reply filed on 6/23/2026 is acknowledged. Claims 21-24 are withdrawn by the Examiner from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election with traverse of Species C and D in the reply filed on 6/23/2026 is acknowledged. Claims 2-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Applicant traverses the separation of each of species A-F on the grounds that no search and/or examination burden exists. This argument is not found to be persuasive. As described in the Restriction Requirement of 4/16/2026, the Examiner believes a search and/or examination burden exists because the species have acquired a separate status in the art in view of their divergent subject matter and the species require a different field of search (i.e. searching different classes/subclasses or electronic resources, or employing different search queries). Specifically, the inward shelf portions and pivotable, spring-biased ledge portion of species A-B are vastly different structures compared to the flexible tabs that snap into place and are removed by the removal tab of species C. Further, the single-piece introducer with flexible legs of species D has a vastly different structure compared to the two separate, rigid introducers of species E and the scissors-type introducer of species F. Each of these species would require searching vastly different text queries. Therefore, the restriction requirement between species is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The three information disclosure statements filed 11/12/2024 fail to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because some of the non-patent literature citations either include improper filing dates or do not include filing dates. See the IDS of 11/12/2024 having 49 pages – NPL citation #48 does not include a filing date. See the IDS of 11/12/2024 having 7 pages – NPL citations #1-3, 32, 34-35 either include improper filing dates or do not include filing dates (note: some of the aforementioned citations appear to have a year followed by a letter, however this format is improper and should be clarified). See the IDS of 11/12/2024 having 26 pages – NPL citations #39, 42, and 48-49 either include improper filing dates or do not include filing dates (note: some of the aforementioned citations appear to have a year followed by a letter, however this format is improper and should be clarified).
The IDSs have been placed in the application file and all references except for the improper references (which have been stricken-through) have been considered by the Examiner. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See par. [0008] of the Specification.
Claim Objections
Claims 1, 7-10, 12, and 16-18 are objected to because of the following informalities:
-Claim 1, line 6: please correct “the at least one top cap lumen” to “the top cap lumen”
-Claim 1, line 7: please correct “therethrough” to “through the top cap lumen”
-Claim 7, lines 2-3: please correct “the circumferentially spaced tabs” to “the plurality of circumferentially spaced tabs”
-Claim 7, line 4: please correct “the circumferentially spaced tabs” to “the plurality of circumferentially spaced tabs”
-Claim 8, lines 1-2: please correct “the circumferentially spaced tabs” to “the plurality of circumferentially spaced tabs”
-Claim 8, lines 3-4: please correct “the circumferentially spaced tabs” to “the plurality of circumferentially spaced tabs”
-Claim 9, line 2: please correct “tabs” to “tab”
-Claim 9, line 4: please correct “the removal tab” to “the at least one removal tab”
-Claim 10, lines 1-2: please correct “the removal tab” to “the at least one removal tab”
-Claim 10, line 2: please correct “the removal tab” to “the at least one removal tab”
-Claim 10, line 3: please correct “actuation” to “the actuation”
-Claim 10, line 3: please correct “the removal tab” to “the at least one removal tab”
-Claim 10, line 4: please correct “the circumferentially spaced tabs” to “the plurality of circumferentially spaced tabs”
-Claim 12, line 6: please correct “the at least one top cap lumen” to “the top cap lumen”
-Claim 12, line 7: please correct “therethrough” to “through the top cap lumen”
-Claim 12, line 9: please correct “therein” to “in the incision port”
-Claim 16, line 2: please correct “gas” to “the gas”
-Claim 17, line 2: please correct “gas” to “the gas”
-Claim 18, line 3: please correct “therein” to “in the top cap seal portion”
Appropriate correction is required.
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.
Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frederick et al. (US 2021/0244439 A1).
Regarding claim 1, Frederick discloses a surgical insertion device (see Figs. 1-4B) comprising:
(a) a flexible canister (canister 12) defining a canister lumen (lumen of canister 12), the flexible canister (canister 12) sized to receive a surgical device (surgical device 26) in the canister lumen (lumen of canister 12) (see Figs. 1A-B, par. [0010], [0200]);
(b) a top cap (top cap 14) coupled to a proximal end of the flexible canister (canister 12), the top cap (top cap 14) comprising a top cap housing (body of top cap 14) and a top cap lumen (lumen through top cap 14) defined in the top cap housing (body of top cap 14), wherein the at least one top cap lumen (lumen through top cap 14) is configured to receive a portion (positioning rod 28) of the surgical device (surgical device 26) slidably disposed therethrough (see Figs. 1A-3B, par. [0200], [0202]-[0203], [0215]); and
(c) an incision port (port 18) coupled to a distal end of the flexible canister (canister 12), the incision port (port 18) comprising at least one downwardly extending ledge (see Figs. 4A-B and 7A-B, connector ring 40 includes a downwardly extending ledge against which upper sleeve ring 46A rests), the at least one downwardly extending ledge (see Figs. 4A-B and 7A-B, connector ring 40 includes a downwardly extending ledge against which upper sleeve ring 46A rests) configured to facilitate coupling an upper ring portion (upper sleeve ring 46A) of a fluidic sealing component (sealable sleeve device 46) to the incision port (port 18), the fluidic sealing component (sealable sleeve device 46) configured to provide a fluidic seal at the incision port (port 18) (see Figs. 4A-B and 7A-B, par. [0200], [0204], [0209], [0214]).
Regarding claim 11, Frederick discloses the surgical insertion device of claim 1 wherein the fluidic sealing component (sealable sleeve device 46) is a sealable sleeve device or a wound retractor seal device (see Figs. 4A-B, par. [0204]).
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.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Frederick et al. (US 2021/0244439 A1), as applied to claim 1 above, in view of Shelton, IV et al. (US 2010/0262080 A1).
Regarding claim 7, Frederick discloses the surgical insertion device of claim 1. However, Frederick fails to state wherein the at least one downwardly extending ledge comprises a plurality of circumferentially spaced tabs, the circumferentially spaced tabs configured to support the upper ring portion of the fluidic sealing component flexibly coupled to an outer portion of the circumferentially spaced tabs.
Shelton, IV teaches a surgical insertion device (see Figs. 15-16) wherein the at least one downwardly extending ledge (vertical ledges of latches 647) comprises a plurality of circumferentially spaced tabs (vertical ledges of latches 647), the circumferentially spaced tabs (vertical ledges of latches 647) configured to support the upper ring portion (outer surface 668 with tabs 667) of the fluidic sealing component (cannula 660) flexibly coupled to an outer portion of the circumferentially spaced tabs (vertical ledges of latches 647) (see Figs. 15-16, par. [0066]-[0067]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of Frederick to divide the at least one downwardly extending ledge into a plurality of circumferentially spaced tabs, the circumferentially spaced tabs configured to support the upper ring portion of the fluidic sealing component flexibly coupled to an outer portion of the circumferentially spaced tabs, as taught by Shelton, IV, in order to introduce latches which can selectively and securely lock and unlock the incision port and the upper ring portion (see Shelton, IV par. [0066]-[0067]).
Regarding claim 8, modified Frederick teaches the surgical insertion device of claim 7 substantially as claimed. Modified Frederick further teaches wherein one or more of the circumferentially spaced tabs (Shelton, IV, vertical ledges of latches 647) is configured to flex radially inward to enable positioning of the upper ring portion (Frederick, upper sleeve ring 46A) of the fluidic sealing component (Frederick, sealable sleeve device 46) around the outer portion of the circumferentially spaced tabs (Shelton, IV, vertical ledges of latches 647) (see previous modifications in rejection of claim 7 above, see Shelton, IV Figs. 15-16 and par. [0066]-[0067], latches 647 flex inward against tabs 667).
Regarding claim 9, modified Frederick teaches the surgical insertion device of claim 8 substantially as claimed. However, modified Frederick fails to state wherein the incision port further comprises at least one removal tab extending outwardly from the incision port, the at least one removal tab configured to enable removal of the fluidic sealing component from the incision port upon actuation of the removal tab.
Shelton, IV teaches a surgical insertion device (see Figs. 15-16) wherein the incision port (cannula base 640) further comprises at least one removal tab (releases 649) extending outwardly from the incision port (cannula base 640), the at least one removal tab (releases 649) configured to enable removal of the fluidic sealing component (cannula 660) from the incision port (cannula base 640) upon actuation of the removal tab (releases 649) (see Figs. 15-16, par. [0066]-[0067]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of modified Frederick to include wherein the incision port further comprises at least one removal tab extending outwardly from the incision port, the at least one removal tab configured to enable removal of the fluidic sealing component from the incision port upon actuation of the removal tab, as taught by Shelton, IV, in order to introduce latches with releases which can selectively and securely lock and unlock the incision port and the upper ring portion (see Shelton, IV par. [0066]-[0067]).
Regarding claim 10, modified Frederick teaches the surgical insertion device of claim 9 substantially as claimed. Modified Frederick further teaches wherein actuation of the removal tab (Shelton, IV, releases 649) comprises outward or downward movement of the removal tab (Shelton, IV, releases 649) relative to the incision port (Frederick, port 18), and wherein actuation of the removal tab (Shelton, IV, releases 649) pulls the upper ring portion (Frederick, upper sleeve ring 46A) of the fluidic sealing component (Frederick, sealable sleeve device 46) away from the circumferentially spaced tabs (Shelton, IV, vertical ledges of latches 647) (see previous modifications in rejection of claims 7-9 above, see Shelton, IV Figs. 15-16 and par. [0066]-[0067], downward pressing on releases 649 pivots releases 649 and latches 647 outward to release latches 647 from tabs 667).
Claims 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Frederick et al. (US 2021/0244439 A1) in view of Beckman et al. (US 2008/0208222 A1).
Regarding claim 12, Frederick discloses a surgical insertion device (see Figs. 70-75C) comprising:
(a) a flexible canister (container 902) defining a canister lumen (lumen of container 902), the flexible canister (container 902) sized to receive a surgical device (surgical device 908) in the canister lumen (lumen of container 902) (see Fig. 70, par. [0331]-[0332]);
(b) a top cap (top cap 904) coupled to a proximal end of the flexible canister (container 902), the top cap (top cap 904) comprising a top cap housing (body of top cap 904) and a top cap lumen (lumen through top cap 904) defined in the top cap housing (body of top cap 904), wherein the at least one top cap lumen (lumen through top cap 904) is configured to receive a portion of the surgical device (surgical device 908) slidably disposed therethrough (see Fig. 70, par. [0331], [0333], [0312], [0315]); and
(c) an incision port (access port 906) coupled to a distal end of the flexible canister (container 902), the incision port (access port 906) comprising an iris sealing mechanism disposed therein (see par. [0342], mechanical iris), the iris sealing mechanism (see par. [0342], mechanical iris) configured to selectively open and close access through a lumen (lumen of access port 906) of the incision port (access port 906) (see Figs. 70-75C, par. [0342]).
However, Frederick fails to show or further describe the structure of the iris sealing mechanism. Specifically, Frederick fails to state that the iris sealing mechanism is configured to selectively open and close access through the lumen of the incision port upon relative rotation of an upper iris component and a lower iris component.
Beckman teaches a surgical insertion device (see Figs. 1-7) comprising an iris sealing mechanism (iris valve 20) configured to selectively open and close access through the lumen of the incision port (access device 10) upon relative rotation of an upper iris component (frame member 30) and a lower iris component (frame member 50) (see Figs. 1-7, par. [0016], [0019]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of Frederick to include wherein the iris sealing mechanism is configured to selectively open and close access through the lumen of the incision port upon relative rotation of an upper iris component and a lower iris component, as taught by Beckman, in order to provide the structure and function of the iris sealing mechanism of Frederick (see Frederick par. [0342], see Beckman par. [0016], [0019]).
Regarding claim 13, modified Frederick teaches the surgical insertion device of claim 12 substantially as claimed. However, modified Frederick fails to state wherein the incision port further comprises a ratchet mechanism associated with the iris sealing mechanism, the ratchet mechanism configured to permit relative rotation of the upper iris component and the lower iris component in a first direction towards closure of the iris sealing mechanism.
Beckman teaches a surgical insertion device (see Figs. 1-7) wherein the incision port (access device 10) further comprises a ratchet mechanism (ratchet 33) associated with the iris sealing mechanism (iris valve 20), the ratchet mechanism (ratchet 33) configured to permit relative rotation of the upper iris component (frame member 30) and the lower iris component (frame member 50) in a first direction towards closure of the iris sealing mechanism (iris valve 20) (see Figs. 1-7, par. [0016], [0019]-[0021], [0023]-[0026]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of modified Frederick to include wherein the incision port further comprises a ratchet mechanism associated with the iris sealing mechanism, the ratchet mechanism configured to permit relative rotation of the upper iris component and the lower iris component in a first direction towards closure of the iris sealing mechanism, as taught by Beckman, in order to provide the structure and function of the iris sealing mechanism of Frederick (see Frederick par. [0342], see Beckman par. [0016], [0019]) in a manner which can selectively lock and unlock the position of position of the iris sealing mechanism (see Beckman par. [0020], [0023]-[0026]).
Regarding claim 14, modified Frederick teaches the surgical insertion device of claim 13 substantially as claimed. However, modified Frederick fails to state wherein the incision port further comprises a release mechanism associated with the iris sealing mechanism, the release mechanism configured to disable the ratchet mechanism upon actuation to permit relative rotation of the upper iris component and the lower iris component in a second direction towards opening of the iris sealing mechanism.
Beckman teaches a surgical insertion device (see Figs. 1-7) wherein the incision port (access device 10) further comprises a release mechanism (control ring 40) associated with the iris sealing mechanism (iris valve 20), the release mechanism (control ring 40) configured to disable the ratchet mechanism (ratchet 33) upon actuation to permit relative rotation of the upper iris component (frame member 30) and the lower iris component (frame member 50) in a second direction towards opening of the iris sealing mechanism (iris valve 20) (see Figs. 1-7, par. [0016], [0019]-[0021], [0023]-[0026]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of modified Frederick to include wherein the incision port further comprises a release mechanism associated with the iris sealing mechanism, the release mechanism configured to disable the ratchet mechanism upon actuation to permit relative rotation of the upper iris component and the lower iris component in a second direction towards opening of the iris sealing mechanism, as taught by Beckman, in order to provide the structure and function of the iris sealing mechanism of Frederick (see Frederick par. [0342], see Beckman par. [0016], [0019]) in a manner which can selectively lock and unlock the position of position of the iris sealing mechanism (see Beckman par. [0020], [0023]-[0026]).
Regarding claim 15, modified Frederick teaches the surgical insertion device of claim 12 substantially as claimed. However, modified Frederick, in the embodiment of Figs. 70-75C, fails to state wherein the incision port further comprises an insufflation port configured to deliver a supply of gas to the lumen of the incision port.
Frederick, in the embodiment of Fig. 83, teaches an alternative surgical insertion device (see Fig. 83) wherein the incision port (incision port 1120) further comprises an insufflation port (insufflation port 1124) configured to deliver a supply of gas to the lumen (lumen of incision port 1120) of the incision port (incision port 1120) (see Fig. 83, par. [0369]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of the modified embodiment of Figs. 70-75C of Frederick to include wherein the incision port further comprises an insufflation port configured to deliver a supply of gas to the lumen of the incision port, as taught by the embodiment of Fig. 83 of Frederick, in order to insufflate the patient’s cavity or provide supplemental insufflation during a procedure (see Frederick par. [0369]).
Regarding claim 16, modified Frederick teaches the surgical insertion device of claim 15 substantially as claimed. Modified Frederick further teaches wherein the insufflation port (see Fig. 83, insufflation port 1124) is configured to deliver gas to the lumen of the incision port (see Fig. 70, access port 906) below the iris sealing mechanism (see Fig. 70, par. [0342], mechanical iris) (see Figs. 70 and 83, par. [0342], [0369], see previous modifications in rejections of claims 12 and 15 above, the iris sealing mechanism of par. [0342] is in the location of slidable lid 944 and the insufflation port 1124 of Fig. 83 is below the slidable lid 1122 such that the insufflation port would be below the iris sealing mechanism).
Regarding claim 17, modified Frederick teaches the surgical insertion device of claim 15 substantially as claimed. Modified Frederick further teaches wherein the insufflation port (see Fig. 83, insufflation port 1124) comprises a valve to selectively permit or restrict flow of gas to the lumen of the incision port (see Fig. 70, access port 906) (see Figs. 70 and 83, par. [0342], [0369], insufflation port 1124 is a flow valve port, see previous modifications in rejections of claims 12 and 15 above).
Regarding claim 18, modified Frederick teaches the surgical insertion device of claim 12 substantially as claimed. However, modified Frederick, in the embodiment of Figs. 70-75C, fails to state wherein the top cap further comprises a top cap seal portion disposed across an upper portion of the top cap lumen, the top cap seal portion having a top cap opening formed therein, the top cap seal portion having a wavy cross-sectional shape to provide flexibility.
Frederick, in the embodiment of Fig. 1-3B, teaches an alternative surgical insertion device (see Figs. 1-3B) wherein the top cap (top cap 14) further comprises a top cap seal portion (seal 30) disposed across an upper portion of the top cap lumen (lumen of top cap 14), the top cap seal portion (seal 30) having a top cap opening (orifice 34) formed therein, the top cap seal portion (seal 30) having a wavy cross-sectional shape to provide flexibility (see Figs. 3A-B, par. [0202]-[0203], seal 30 is shown to have a wavy shape in Figs. 3A-B).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of the modified embodiment of Figs. 70-75C of Frederick to include wherein the top cap further comprises a top cap seal portion disposed across an upper portion of the top cap lumen, the top cap seal portion having a top cap opening formed therein, the top cap seal portion having a wavy cross-sectional shape to provide flexibility, as taught by the embodiment of Figs. 1-3B of Frederick, in order to provide a simpler top cap seal for procedures where only a single surgical instrument needs to be inserted therethrough (see Frederick par. [0202]-[0203]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Frederick et al. (US 2021/0244439 A1) in view of Beckman et al. (US 2008/0208222 A1), as applied to claim 18 above, further in view of Duke et al. (US 2011/0237901 A1).
Regarding claim 19, modified Frederick teaches the surgical insertion device of claim 18 substantially as claimed. However, modified Frederick fails to state wherein the top cap seal portion is formed of molded silicone having a durometer value in a range of from 00 to 50.
Duke teaches a surgical insertion device (see Fig. 6) wherein the top cap seal portion (seal 2000) is formed of a molded silicone having a durometer value in a range of from 00 to 50 (see par. [0015], [0069]-[0070]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of modified Frederick to include wherein the top cap seal portion is formed of molded silicone having a durometer value in a range of from 00 to 50, as taught by Duke, in order to provide a relatively soft material capable of maintaining a fluid seal while preventing the need for a large clamping force to secure the top cap seal portion within the top cap (see Duke par. [0015], [0069]-[0070]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Frederick et al. (US 2021/0244439 A1) in view of Beckman et al. (US 2008/0208222 A1), as applied to claim 18 above, further in view of Duke et al. (US 2011/0237901 A1), and further in view of Ho et al. (US 2022/0401031 A1).
Regarding claim 20, modified Frederick teaches the surgical insertion device of claim 18. However, modified Frederick fails to state wherein the top cap seal portion is formed of molded silicone and has a Parylene-C coating.
Duke teaches a surgical insertion device (see Fig. 6) wherein the top cap seal portion (seal 2000) is formed of molded silicone (see par. [0015], [0069]-[0070]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of modified Frederick to include wherein the top cap seal portion is formed of molded silicone, as taught by Duke, in order to provide a relatively soft material capable of maintaining a fluid seal while preventing the need for a large clamping force to secure the top cap seal portion within the top cap (see Duke par. [0015], [0069]-[0070]).
However, modified Frederick still fails to state wherein the top cap seal portion has a Parylene-C coating.
Ho teaches a surgical device (see Fig. 5) insertable into the body and sealed with a parylene-C coating (see par. [0022], [0128]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical insertion device of modified Frederick to coat the top cap seal portion with Parylene-C, as suggested by Ho, because Parylene-C coatings on implantable medical devices are biocompatible and prevent unwanted side-effects from occurring within the body (see Ho par. [0022], [0128]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
