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 .
Status of the Claims
This Office Action is responsive to the amendment filed January 26, 2026. As directed by the amendment: Claims 1, 23, and 27 have been amended. Claims 2-12 and 22 were cancelled. Claims 1, 13-21, and 23-27 are presently pending in this application.
Examiner’s Note
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.
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.
Claim(s) 1, 13-15, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederick et al. (US 2019/0046234), herein referred to as Frederick, and in view of Patel et al. (US 2017/0071629), herein referred to as Patel.
Regarding claims 1, 13, Frederick discloses a medical device (figure 55) comprising a flexible envelope (802) (¶310) comprising distal and proximal openings (figures 57A and 62A), a distal coupling component (850) positioned in and coupled to the distal opening (figures 62A and 62B), and a proximal coupling component (804) positioned in and coupled to the proximal opening (figures 57A and 57B), the proximal coupling component (804) comprising an entry guide port (814), wherein the envelope (802) includes a proximal section (portion of element 802) coupled to a distal section (considered as another portion of element 802) at a junction (defined as “a place or point of meeting” by Merriam Webster’s Dictionary), the proximal opening being in the proximal section (figures 55, 57A, 57B), and the distal opening being in the distal section (figures 62A and 62B).
Yet, Frederick lacks wherein the envelope includes a convex proximal section coupled to a convex distal section at junction, the proximal opening being in the convex proximal section, and the distal opening being in the convex distal section, a maximum diameter of the envelope is located at the junction between the convex proximal and distal sections of the envelope, the envelope, on condition that the envelope is pressurized with insufflation gas, comprises an ovoid shape that extends radially outward beyond the distal and proximal openings and the distal and proximal coupling components and is formed by the convex proximal section coupled to the convex distal section at the maximum diameter junction, and the junction at which the convex distal section is coupled to the convex proximal section of the envelope is located below a plane that bisects the envelope longitudinally such that a proximal-distal extent of the convex proximal section is larger than a proximal-distal extent of the convex distal section, wherein a maximum diameter of the envelope is larger than a height of the envelope.
However, Frederick discloses the canister can have alternative shapes (¶11 and figures 84A and 84B). Furthermore, Patel teaches a sheath (22) having an oval (ovoid) or more complex shape (¶53).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frederick’s medical device with wherein the envelope includes a convex proximal section coupled to a convex distal section at junction, the proximal opening being in the convex proximal section, and the distal opening being in the convex distal section, a maximum diameter of the envelope is located at the junction between the convex proximal and distal sections of the envelope, the envelope, on condition that the envelope is pressurized with insufflation gas, comprises an ovoid shape that extends radially outward beyond the distal and proximal openings and the distal and proximal coupling components and is formed by the convex proximal section coupled to the convex distal section at the maximum diameter junction, and the junction at which the convex distal section is coupled to the convex proximal section of the envelope is located below a plane that bisects the envelope longitudinally such that a proximal-distal extent of the convex proximal section is larger than a proximal-distal extent of the convex distal section, wherein a maximum diameter of the envelope is larger than a height of the envelope, since such a modification is considered a change in shape that is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 14, the modified Frederick’s medical device has wherein the envelope (the modified Frederick’s envelope) comprises a thermoplastic polyurethane (¶310 of Frederick).
Regarding claim 15, the modified Frederick’s medical device has wherein the distal coupling component (850 of Frederick) is configured to (i.e. capable of) be coupled to a medical port device (806 of Frederick).
Regarding claim 23, Frederick discloses a medical device (figure 55) comprising a flexible envelope (802) (¶310) comprising a proximal section (portion of element 802) and a distal section (considered as another portion of element 802), the proximal section (portion of element 802) comprising a proximal opening (figure 57A), the distal section (considered as another portion of element 802) being joined to the proximal section (figure 55) and comprising a distal opening (figure 62A), a center axis (considered as a longitudinal axis) being defined through the proximal and distal openings (figures 57A and 62A), means for receiving a plurality of instruments (considered as a proximal coupling e.g. 804) (figure 55), the means for receiving (considered as a proximal coupling e.g. 804) being coupled to the envelope (802) at the proximal opening (figures 57A and 57B) and comprising an entry guide port (considered as element 824) (¶311 and figures 56A and 56B) and an assistant port (considered as another element 824) (¶311 and figures 56A and 56B), the entry guide port (considered as element 824) and the assistant port (considered as another element 824) both being eccentrically positioned (figures 56A and 56B) on the means for receiving (considered as a proximal coupling e.g. 804), means for coupling (considered as a distal coupling component) to a medical port device (806), the means for coupling (considered as a distal coupling component) being coupled to (i.e. capable of) the envelope (802) at the distal opening (figures 62A and 62B).
Yet, Frederick lacks the envelope comprising a convex proximal section and a convex distal section, the convex proximal section comprising a proximal opening, the convex distal section being joined to the convex proximal section, wherein a maximum diameter of the envelope is located at a junction between the convex proximal and distal sections of the envelope, and on condition that the envelope is insufflated by a gas, the envelope comprises a generally ovoid shape formed by with the convex proximal section extending a first distance along the center axis joined to the convex distal section extending along a second distance along the center axis less than the first distance, and the envelope extends radially outward beyond the distal and proximal openings, the means for receiving, and the means for coupling.
However, Frederick discloses the canister can have alternative shapes (¶11 and figures 84A and 84B). Furthermore, Patel teaches a sheath (22) having an oval (ovoid) or more complex shape (¶53).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frederick’s medical device with the envelope comprising a convex proximal section and a convex distal section, the convex proximal section comprising a proximal opening, the convex distal section being joined to the convex proximal section, wherein a maximum diameter of the envelope is located at a junction between the convex proximal and distal sections of the envelope; and on condition that the envelope is insufflated by a gas, the envelope comprises a generally ovoid shape formed by with the convex proximal section extending a first distance along the center axis joined to the convex distal section extending along a second distance along the center axis less than the first distance, and the envelope extends radially outward beyond the distal and proximal openings, the means for receiving, and the means for coupling, since such a modification is considered a change in shape that is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 24, the modified Frederick’s medical device has wherein at least a part of the proximal section (portion of element 802 of Frederick) is transparent (¶310 of Frederick).
Regarding claim 25, the modified Frederick’s medical device discloses all the features/elements as claimed but lacks wherein the convex proximal section consists of a first individual piece, and the convex distal section consists of a second individual piece.
However, Frederick teaches in an alternative embodiment, the balloon (envelope) can be part of a single integral piece or can be made up of separate components (¶225). Furthermore, it is known that constructing a formerly integral structure in various elements involves only routine 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 modify the modified Frederick’s medical device with wherein the convex proximal section consists of a first individual piece, and the convex distal section consists of a second individual piece, since it is known that constructing a formerly integral structure in various elements involves only routine skill in the art.
Claim(s) 20, 21, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederick and Patel as applied to claims above, and further in view of Leachy et al. (US 5,813,409), herein referred to as Leachy.
Regarding claims 20, 21, the modified Frederick’s medical device discloses all the features/elements as claimed but lacks further comprising an assistant port coupled to the envelope between the proximal opening and the distal opening of the envelope and further comprising an instrument seal in the assistant port.
However, Leachy teaches an assistant port (62) coupled to an envelope (52) between a proximal opening (figure 5) and a distal opening (figure 5) of the envelope (52) and further comprising an instrument seal (62c) in the assistant port (62) (figure 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Frederick’s medical device with an assistant port coupled to the envelope between the proximal opening and the distal opening of the envelope and an instrument seal in the assistant port as taught by Leachy, since such a modification would provide direct access for instruments to be inserted into an envelope without losing insufflation pressure, if any is present (col. 4, Il. 59-61).
Regarding claim 26, the modified Frederick’s medical device discloses all the features/elements as claimed but lacks wherein the envelope comprises a third opening between the proximal and distal openings, and the medical device comprises second means for receiving one or more instruments, the second means for receiving being in the third opening of the envelope.
However, Leachy teaches a third opening (figure 5) between proximal and distal openings (figure 5), and a medical device (figure 5) comprises an assistant port (62) (second means) for receiving one or more instruments (col. 4, Il. 59-61), the assistant port (62) (second means) for receiving being in the third opening of the envelope (52) (figure 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Frederick’s medical device with wherein the envelope comprises a third opening between the proximal and distal openings, and the medical device comprises second means for receiving one or more instruments, the second means for receiving being in the third opening of the envelope as taught by Leachy, since such a modification would provide direct access for instruments to be inserted into an envelope without losing insufflation pressure, if any is present (col. 4, Il. 59-61).
Allowable Subject Matter
Claims 16-19 and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed January 26, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 6-13, under 35 U.S.C. 103, of the Remarks are directed to the amended claims 1 and 23 and the combination of references (Frederick in view of Patel). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. Thus, a change in shape is generally recognized as being within the level of ordinary skill in the art.
Applicant argues that “Applicant's claims recite a particular shape that is markedly different than that of the Frederick device and which has particular characteristics and associated advantages/benefits in applications germane to Applicant's claimed invention(s) and which are not contemplated or recognized in any manner in Frederic.” However, the Examiner respectfully disagrees because the originally filed disclosure states in paragraph 9 that “The envelope may have various shapes, such as a spheroid shape, ellipsoid shape, ovoid shape, barrel shape, lenticular shape, or bellows shape, for example”. Thus, it appears there is no criticality or unexpected result for this particular shape. The Examiner notes that the reference Frederick teaches the canister can have alternative shapes (¶11 and figures 84A and 84B). The reference Patel teaches a sheath (22) having an oval (ovoid) or more complex shape (¶53). Thus, a change in shape is generally recognized as being within the level of ordinary skill in the art. Applicant is suggested to provide additional structure.
Applicant further argues the amended feature of “a flexible envelope”. The reference Frederick discloses a flexible envelope (802) (¶310).
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.
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/SI MING KU/Primary Examiner, Art Unit 3775