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 Species A in the reply filed on 03/09/2026 is acknowledged.
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) 2-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franer (US 2012/0004613 A1).
Regarding claim 2, Franer discloses (see abstract; paras. [0012]-[0031]; figs. 1-5) a surgical access assembly (fig. 1) comprising:
a housing (18 formed by 110 and 34, para. [0014]; fig. 1) comprising a central axis through a longitudinal passage (fig. 1);
a valve assembly (includes closure valve 40, seal 80 and protectors 90, paras. [0013] and [0015]; fig. 2) movable radially within the longitudinal passage of the housing (via bellows 70, para. [0016]), the valve assembly comprising an instrument seal (80) and a guard (90);
a centering ring (70, fig. 3) within the housing (fig. 2) and having an outer annular ring (outermost ring depicted in fig. 3) that surrounds the valve assembly (figs. 2-5); and
a retainer (includes 100 and 60, para. [0015]) comprising a plurality of pins (posts, fig. 2) passing through corresponding bores in the guard, the centering ring, and the instrument seal (para. [0015]),
wherein the centering ring permits radial movement of the valve assembly relative to the central axis of the housing (allows assembly to float, paras. [0013] and [0016]).
Regarding claim 3, Franer discloses the surgical access assembly of claim 2. Franer further discloses wherein the centering ring comprises a bellows (para. [0015]).
Regarding claim 4, Franer discloses the surgical access assembly of claim 3. Franer further discloses wherein the bellows returns the valve assembly to a centered position in which a central opening of the centering ring and the central axis of the housing are coaxial (via floating, paras. [0013] and [0016]).
Regarding claim 5, Franer discloses the surgical access assembly of claim 3. Franer further discloses wherein the centering ring comprises an inner annular ring that supports the guard (see inner ring depicted in fig. 3).
Regarding claim 6, Franer discloses the surgical access assembly of claim 2. Franer further discloses wherein the instrument seal comprises a frame (86, para. [0017]; fig. 3) connected to a plurality of petals (89).
Regarding claim 7, Franer discloses the surgical access assembly of claim 6. Franer further discloses wherein the frame is integrally formed as a monolithic structure (unitary part, para. [0029]).
Regarding claim 8, Franer discloses the surgical access assembly of claim 6. Franer further discloses wherein the frame forms a boundary that defines a passage through the instrument seal (figs. 2-5).
Regarding claim 9, Franer discloses the surgical access assembly of claim 6. Franer further discloses wherein the plurality of petals fold in an interlocking pattern into a folded configuration (pleats 89 considered to fold, as the term “pleat” is defined as a fold, see also figs. 3-5 depicting pleats 89 in an interlocking pattern by being connected to each other).
Regarding claim 10, Franer discloses the surgical access assembly of claim 6. Franer further discloses wherein the plurality of petals flex in a distal direction during insertion of a surgical instrument through the longitudinal passage (pleats 89 taper distally, considered to flex in the distal direction when an instrument is inserted, para. [0027]; figs. 3-5).
Regarding claim 11, Franer discloses the surgical access assembly of claim 2. Franer further discloses wherein the retainer maintains an aligned relationship of the guard, the centering ring, and the instrument seal (para. [0015]).
Regarding claim 12, Franer discloses the surgical access assembly of claim 11. Franer further discloses wherein the retainer comprises a first ring (100) having the plurality of pins (posts, para. [0015]), and a second ring (60) having a plurality of openings (holes) that aligns with the plurality of pins (para. [0015]).
Regarding claim 13, Franer discloses the surgical access assembly of claim 2. Franer further discloses wherein the corresponding bores in the instrument seal, the guard, and the centering ring comprise a set of bores in the guard, a set of pores in the centering ring, and a set of holes in the instrument seal (para. [0015]; fig. 2).
Regarding claim 14, Franer discloses (see abstract; paras. [0012]-[0031]; figs. 1-5) a surgical access assembly (fig. 1) comprising:
a housing (18 formed by 110 and 34, para. [0014]; fig. 1) comprising a central axis through a longitudinal passage (fig. 1);
a cannula (16, para. [0014]) having a proximal end attached to the housing and an opposite distal end (fig. 1);
a valve assembly (includes closure valve 40, seal 80 and protectors 90, paras. [0013] and [0015]; fig. 2) movable radially within the longitudinal passage of the housing (via bellows 70, para. [0016]), the valve assembly comprising an instrument seal (80) and a guard (90), wherein the instrument seal comprises four or more petals (pleats 89, see at least 4 depicted in figs. 2-5, para. [0017]) foldable around a central hole (pleats by definitions are folds, figs. 2-5);
a centering ring (70, fig. 3) having an outer annular ring (outermost ring depicted in fig. 3) that surrounds the valve assembly (figs. 2-5); and
a retainer (includes 100 and 60, para. [0015]) comprising a first ring (100) and a second ring (60), the first ring having a plurality of pins (posts, fig. 2) passing through corresponding openings in the second ring (para. [0015]),
wherein the instrument seal, the guard, and the centering ring are sandwiched between the first and second rings (para. [0015]), and
wherein the centering ring permits radial movement of the valve assembly relative to the central axis of the housing (allows assembly to float, paras. [0013] and [0016]).
Regarding claim 15, Franer discloses the surgical access assembly of claim 14. Franer further discloses wherein the four or more petals are movable between unfolded, partially folded, and folded configurations (pleats by definition are folds, pleats 89 formed of an elastic material that expands/relaxes to sealingly engage instruments inserted through the central hole, such that pleats are considered to have multiple configurations encompassing an unfolded, partially folded and folded configuration, dependent on the size of the instrument inserted through the central hole, such that pleats would form a more folded or less folded configuration as claimed, para. [0017]; figs. 2-5).
Regarding claim 16, Franer discloses the surgical access assembly of claim 14. Franer further discloses wherein the plurality of pins pass through corresponding bores in the guard, the centering ring, and the instrument seal (para. [0015]).
Regarding claim 17, Franer discloses the surgical access assembly of claim 14. Franer further discloses wherein the plurality of pins align relative positions of the guard, the centering ring, and the instrument seal (para. [0015]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2007/0185453 A1 to Michael, disclosing a conical trocar seal.
US 2021/0213269 A1 to Venskytis, disclosing an instrument seal.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771