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 .
Response to Amendment
The amendments filed on 02/26/2026 have been entered. Claims 1-20 remain pending in the application. The amendments overcome the rejection under 35 USC 112(b) set forth in the previous rejection dated 08/26/2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 in view of Fischvogt have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
This application contains claims directed to the following patentably distinct species:
Species A, encompassing FIGs 1-4, wherein the flexible opening member is a compliant air sealing gasket, referred to as a passive sealing port.
Species B, encompassing FIGs 5A-5B, wherein the flexible opening member is a inflatable sealing port, referred to as an active sealing port.
The species are independent or distinct because they recite mutually exclusive characteristics of a flexible opening member. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claim 20 appears to be generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification
The species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter
The species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with David Bassett on 03/11/2026 a provisional election was made without traverse to prosecute the invention of Species B, encompassing claims 7, 8, 16-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-6 and 9-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Claim(s) 7, 8, 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wachli et al. (US 2016/0045220).
Regarding claim 16, Wachli et al. discloses a surgical apparatus (6100, particularly the embodiment of FIG 6H-6K, [0070-0074] and having the cap embodiment of FIG 11A-11F, [0135-0140], which [0095] discloses is sealingly coupled to the outer ring 6120 of the main embodiment) for insertion into an annular orifice of an animal body (Natural orifice such as the vagina, abstract, [0003, 0007-0008, 0073]) to provide access to a cavity defined by the animal body while the surgical apparatus creates a seal within the annular orifice to maintain pneumoperitoneum during a surgical procedure ([0073]), the surgical apparatus comprising: a) a central support member (6130, 6140, 6120, FIG 6H, and cap ring 11510 and pad 11530, FIG 11A); b) an outer expandable member (6132, FIG 6H, [0070-0074]) that coupled to the central support member (coupled to 6130, FIG 6J), wherein the outer expandable member is configured to expand to create a seal with the annular orifice ([0070, 0073]); c) a flexible opening member (11540, comprising 11542 and 11544, [0135]) disposed within the central support member (FIG 11A shows the ports are disposed within 11530 of the central support member), wherein the flexible opening member has a first state (The seal is closed such as in FIG 11A) and a second state (The seal is open such as when an instrument is passed therethrough, FIG 11D), wherein in the first state, the flexible opening member is normally closed or sealed to prevent fluidic communication between opposing sides of the flexible opening member ([0137] “the second seal 11544 forms a zero seal in the absence of an instrument extending there through”), and wherein in the second state, a device or an instrument is passed through the flexible opening member and the flexible opening member conforms and seals against the device or the instrument to prevent fluidic communication between opposing sides of the flexible opening ([0137-0140], “thus, during use, the septum seal provides an instrument seal in the presence of an instrument inserted there through, and the duckbill valve provides a zero seal in the absence of an instrument inserted there through”) wherein further the flexible opening member is comprised of a duckbill valve ([0139-0140] disclose 11544 as a duckbill valve).
Regarding claim 17, Wachli et al. discloses the outer expandable member is adjustably expandable to control the contact and seal with the annular orifice to resist the flow of fluid between the cavity and an ambient operating room pressure (The level of inflation of 6132 can be controlled by inflation port 6134 using a syringe, bulb pump or other source of gas or fluid, [0074]. Therefore, it can be adjusted to achieve the desired contact at a particular ambient pressure).
Regarding claim 18, Wachli et al. discloses the outer expandable member is configured to be inflatable using an external inflation device ([0074] discloses 6132 is configured to be inflated using a bulb pump) and wherein the external inflation devices include a pressurization source for providing a fluid volume within a cavity defined by the outer expandable member (Examiner notes the external inflation device and pressurization source are not positively recited elements of the claim, the bulb pump of Wachli teaches a pressurized source of fluid volume), wherein the fluid volume is provided manually or automatically by the pressurization source (A bulb pump is understood to be manually operated to expel fluid) which expands the outer expandable member to maintain the seal with the annular orifice ([0070-0073]).
Regarding claim 19, Wachli discloses a first side of the apparatus is configured to face a surgical procedure within the cavity ([0073] the distal end of the device having the outer expandable member is inserted into the vaginal cavity, therefore the bottom side of the device as viewed in FIG 6H faces body cavity, which is understood to be where a surgical procedure would occur), wherein a second side of the apparatus is configured to face a surgeon using the apparatus (The top side at ring 6120 which is where clap 11510 is located faces the outside of the body and therefore is facing a surgeon for insertion of the instruments therein), wherein the apparatus is configured to isolate the cavity pneumoperitoneum pressure from ambient atmospheric pressure (Because the orifice is completely sealed), wherein the apparatus is further configured to allow the surgeon to insert the device or the instrument through the flexible opening member into the cavity (FIG 11D, instruments 11550, [0140]), whereupon the flexible opening member is further configured both to expand by the insertion of the device or the instrument and to seal against an outer surface of the device or instrument which allows for maintaining pneumoperitoneum pressure therein the apparatus is further configured to allow for the passage of the device or the instrument into the cavity ([0140] discloses the seals expand and contract to accept the instrument passing therethrough or allow for the instrument to be removed while still maintaining the seal).
Regarding claim 7, Wachli discloses the flexible opening member and the device or the instrument both have outer surfaces configured to ensure the seal between the flexible opening member and the device or the instrument ([0138-0140]).
Regarding claim 8, Wachli discloses said flexible opening member is a normally collapsed aperture in the first state (As is shown in the state of FIG 11A before an instrument is passed therethrough, “duckbill valve provides a zero seal in the absence of an instrument inserted there through”), and wherein in the second state the aperture is expandable to permit non-permanent displacement and penetration by, yet circumferentially sealed about, the outer surface of the device or the instrument ([0138-0140] “When an instrument is inserted through the aperture 11546 of the septum seal, the aperture 11546 expands and engages the outer surface of the instrument, thereby forming a seal therewith. The septum seal comprises an elastomeric material that biases the aperture against an instrument is inserted there through”).
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.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wachli et al. (US 2016/0045220).
Regarding claim 20, Wachli et al. discloses a surgical apparatus (6100, particularly the embodiment of FIG 6H-6K, [0070-0074] and having the cap embodiment of FIG 11A-11F, [0135-0140], which [0095] discloses is sealingly coupled to the outer ring 6120 of the main embodiment) for insertion into an annular orifice of an animal body (Natural orifice such as the vagina, abstract, [0003, 0007-0008, 0073]) to provide access to a cavity defined by the animal body while the surgical apparatus creates a seal within the annular orifice to maintain pneumoperitoneum during a surgical procedure ([0073]), the surgical apparatus comprising: a) a central support member (6130, 6140, 6120, FIG 6H, and cap ring 11510 and pad 11530, FIG 11A); b) an outer expandable member (6132, FIG 6H, [0070-0074]) that coupled to the central support member (coupled to 6130, FIG 6J), wherein the outer expandable member is configured to expand to create a seal with the annular orifice ([0070, 0073]); c) a flexible opening member (11540, comprising 11542 and 11544, [0135]) disposed within the central support member (FIG 11A shows the ports are disposed within 11530 of the central support member), wherein the flexible opening member has a first state (The seal is closed such as in FIG 11A) and a second state (The seal is open such as when an instrument is passed therethrough, FIG 11D), wherein in the first state, the flexible opening member is normally closed or sealed to prevent fluidic communication between opposing sides of the flexible opening member ([0137] “the second seal 11544 forms a zero seal in the absence of an instrument extending there through”), and wherein in the second state, a device or an instrument is passed through the flexible opening member and the flexible opening member conforms and seals against the device or the instrument to prevent fluidic communication between opposing sides of the flexible opening ([0137-0140], “thus, during use, the septum seal provides an instrument seal in the presence of an instrument inserted there through, wherein further the outer expandable member is configured to create the seal with the annular orifice at a single continuous annular perimeter (The toroid shape of the outer expandable member forms a single continuous annular perimeter) and the flexible opening member is configured to seal with the central support member at a single continuous annular perimeter (FIG 11A, any one of 11540 forms a single continuous annular perimeter withing 11530 of the central support member).
Wachli is silent regarding the respective thickness of the flexible opening member and the outer expandable member and therefore fails to disclose the thickness of the flexible opening member is at least 2 times the thickness of the outer expandable member at the outer edge of the flexible opening member which is configured to create the seal with the annular orifice.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the flexible opening member to be twice as thick as the outer expandable member since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Wachli et al. would not operate differently with the claimed wall thicknesses since the flexible opening member comprises at least two layers (first and second seals) and the wall of the outer expandable member is intended to elastically deform in order to expand and contract, the device would function appropriately having the claimed thicknesses. Further, applicant places no criticality on the relationship claimed, indicating simply that ”In one aspect of the present invention, the walls of bladder 112 are substantially thinner (e.g., at least 2X) than the thickness of penetrable sealing port 118” ([0032]).
Conclusion
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771