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
As of the reply filed 7/22/2026, claims 1-4, 7-10, and 11-22 are pending. Claims 11-20 have been withdrawn, claims 21-22 are new, and claim 1 has been amended.
Response to Arguments
Applicant’s amendment to claim 1 has overcome the previously filed claim objection, therefore this objection is withdrawn.
Applicant's arguments filed 7/22/2026 have been fully considered but they are not persuasive.
With respect to the Applicant’s argument that “even if Franer’s floating seal assembly were hypothetically combined with Jiang’s sheath handle, and Ventskytis’ upper and lower pucks and septum seal were hypothetically combined with Jiang/Fraser, the resulting structure would still not arrive at the specific architecture recited in amended claim 1” (see Remarks page 11), the Examiner respectfully disagrees. Franer teaches the floating seal assembly as claimed, comprising a deformable annulus (72 in Fig. 4) and a seal (80), wherein there is a gap between the deformable annulus and seal (80, see gap defined by 77 and 87) due to their discrete, separate constructions. Venskytis et al. teaches the rigid annulus (228 and 230 in Fig. 4) that sandwiches outer/inner edges of the seal and deformable annulus (243 and 250), respectively. The Examiner argues that the claimed construction would have been obvious to one of ordinary skill in the art given the respective teachings of Franer and Venskytis et al., as the modification as proposed would simply incorporate the rigid annulus holding structure of Venskytis et al. between the separate deformable annulus and seal as taught by Franer. Although Venskytis et al. discusses the benefits of a unitarily constructed deformable annulus and seal (see PP [0078]), the Examiner argues that this does not teach away from the proposed modification as it does not render the prior art unsatisfactory for its intended purpose or change the principle of operation of the device, but simply yields the predictable result of requiring alignment of the deformable annulus and seal during assembly of the device (see PP [0078]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US PGPub 2021/0316128 A1) in view of Franer (US Patent No. 7,789,861 B2) and Venskytis et al. (US PGPub 2021/0213269 A1).
With respect to claim 1, Jiang et al. discloses a handle (54 in Fig. 18) configured for a sheath introducer (catheter sheath assembly 100 is intended for introducing catheters, therefore handle 54 is configured for a sheath introducer), the handle (54) comprising:
an elongated handle housing (exterior housing of 54);
an elongated shaft (50) disposed within the elongated handle housing (54, see Figs. 19-25, the tube 50 extends through the handle housing 54 to allow passage of a dilator 70, PP [0041]: “The hemostatic valve 20 is arranged at or close to a proximal end of the tube body 50. Further, the sheath 10 also includes a handle 54 arranged at the proximal end of the tube body 50”) and comprising a lumen concentric to a longitudinal axis of the handle (see Figs. 19-25, the lumen of 50 lines up with a longitudinal axis of 54);
a seal (20) comprising an opening (see cavity 256 in Fig. 22) substantially centered with the longitudinal axis (see Fig. 22).
However, Jiang et al. fails to disclose the seal being constrained to translate in an orthogonal direction in relation to the longitudinal axis in response to a force applied to the seal along or at an angle to the longitudinal axis, the seal comprising an outer perimeter comprising an outer edge;
a deformable annulus comprising an inner perimeter fixed in relation to the seal and an outer perimeter fixed in relation to the elongated handle housing, the inner perimeter comprising an inner edge of the deformable annulus; or
a rigid annulus affixed to the seal and affixed to the inner perimeter of the deformable annulus and comprising a proximal portion and a distal portion such that (i) the outer edge of the seal is sandwiched between the proximal portion and the distal portion and (ii) the inner edge of the deformable annulus is sandwiched between the proximal portion and the distal portion along the longitudinal axis to affix the rigid annulus and the inner perimeter of the deformable annulus, and (iii) the rigid annulus is interposed, in a region where the outer edge of the seal and the inner edge of the deformable annulus are sandwiched between the proximal portion and the distal portion, between the outer edge of the seal and the inner edge of the deformable annulus in the orthogonal direction such that a gap is defined between the seal and the deformable annulus, the rigid annulus being constrained to move orthogonally in relation to the longitudinal axis in response to the force applied to the seal.
In the same field of hemostatic valves (abstract), Franer teaches a trocar seal assembly (see Figs. 1 and 4) comprising a seal (see Fig. 4) constrained to translate orthogonally in relation to a longitudinal axis of the device in response to a force applied to the seal (col. 3, lines 1-2: “The pleats (72) provide lateral pliancy so the assembly (120) can float”) along or at an angle to the longitudinal axis (since the assembly 120 can float/move laterally, the seal is configured to translate orthogonally in response to a force along or at an angle to the longitudinal axis);
a deformable annulus (72 in Fig. 4) comprising an inner perimeter (radially inner portion of 72 attached to 76) fixed in relation to the seal (80) and an outer perimeter (radially outer portion of 72 attached to 74) fixed in relation to a housing of the device (col. 4, lines 18-20: “The lateral flange (74) is compressed between the retainer ring (50) and the upper body (110) to provide a seal against the housing wall”), the inner perimeter comprising an inner edge of the deformable annulus (72, the inner radial end of 72 can be considered to be an inner edge); and
a rigid annulus (76 and 86 in Fig. 4 of Franer) affixed to the seal (80) and affixed to the inner perimeter of the deformable annulus (radially inner portion of 72) and comprising a proximal portion (86 is upper/more proximal) and a distal portion (76 is lower/more distal) such that an outer perimeter (85) of the seal is positioned between the proximal portion and the distal portion (85 extends between 86 and 76 to connect the seal to both portions, see Fig. 4), the rigid annulus (76 and 86) being constrained to move orthogonally in relation to the longitudinal axis in response to the force applied to the seal (col. 3, lines 1-2: “The pleats (72) provide lateral pliancy so the assembly (120) can float”, since 76 and 86 are attached to 72 they are constrained to move orthogonally), and a gap is defined between the seal (80) and the deformable annulus (72, see radial gap between 80 and 72 in Fig. 4 since Franer discloses that these components are separate, col. 4, lines 24-25: “the bellows (70) and instrument seal (80) are shown in this example as separate parts”).
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Jiang et al. device to incorporate the teachings of Franer and include a seal constrained to translate orthogonally in response to an applied force as claimed. One of ordinary skill in the art would have been motivated to perform this modification because it would have been a simple substitution of hemostatic seals in such a way as to obtain predictable results, since the Jiang et al. device would operate the same with the seal structure as taught by Franer.
Jiang et al. as modified by Franer further fails to disclose wherein the inner edge of the deformable annulus is sandwiched between the proximal portion and the distal portion along the longitudinal axis, an outer perimeter of the seal is positioned between the proximal portion and the distal portion, the rigid annulus is interposed, in a region where the outer edge of the seal and the inner edge of the deformable annulus are sandwiched between the proximal portion and the distal portion, between the outer edge of the seal and the inner edge of the deformable annulus in the orthogonal direction, the rigid annulus being constrained to move orthogonally in relation to the longitudinal axis in response the force applied to the seal, since the deformable annulus (72 in Fig. 4 of Franer) is merely attached to the proximal portion (76) and not sandwiched between the proximal portion (76) and the distal portion (86).
In the same field of instrument seal assemblies (abstract), Venskytis et al. teaches a seal assembly (200 in Fig. 3A) comprising a seal (243) and a deformable annulus (250, PP [0076]: “The bellows portion may allow side-to-side movement (e.g., perpendicular to an instrument insertion axis) of the puck assembly 220, which may protect the septum portion 243 of the septum seal 212 as an instrument is manipulated in a cannula or allow for greater range of motion or easier movement of an instrument shaft by a clinician or by a teleoperated surgical system controlled by a clinician”) comprising an inner edge (right-most end of 250 closest to 228 and 230) and further teaches a rigid annulus (228 and 230) comprising a proximal portion (228) and a distal portion (230), wherein the inner edge of the deformable annulus (250) is sandwiched between the proximal portion (228) and the distal portion (230) along the longitudinal axis (see Fig. 3C that shows unmarked annulus 250 extending between the proximal and distal portions), the rigid annulus (228 and 230) is interposed, in a region where the outer edge of the seal (radially outward edge of 243) and the inner edge of the deformable annulus (radially inward edge of 250) are sandwiched between the proximal portion and the distal portion (see 250 and 243 sandwiched between 228 and 230), between the outer edge of the seal (243) and the inner edge of the deformable annulus (250) in the orthogonal direction, the rigid annulus (228 and 230) being constrained to move orthogonally in relation to the longitudinal axis in response the force applied to the seal (PP [0076]: “The bellows portion may allow side-to-side movement (e.g., perpendicular to an instrument insertion axis) of the puck assembly 220”, 228 and 230 are part of the puck assembly 220”, PP [0078]: “the upper puck part 228 may be coupled to the lower puck part 230 by inserting the protrusions 262 into holes in the receiving portions 264 of the upper puck part 228, which holds the upper puck part 228, lower puck part 230, flaps 202, 204, 206, 208 and septum seal 212 together to form the puck assembly 220”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Jiang et al. and Franer combination to further include the teachings of Venskytis et al. and incorporate the annulus connection as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes the use of a known technique to improve a similar device in the same way to yield predictable results, as modifying the Franer seal to include the sandwiched retention structure taught by Venskytis et al. would not have altered the main operating principle of Franer. Additionally, Venskytis et al. teaches that this form of sandwiched assemblage may be “advantageously simple” (PP [0078], please note that the “puck assembly” is equivalent to the rigid annulus assembly as claimed), which would provide benefits in manufacturing of the device. Furthermore, the combination as proposed would maintain the gap between the seal and deformable annulus as described above, because Venskytis et al. does not teach away from the deformable annulus and seal being separate parts, but merely states that further alignment is necessary in assembling separate components (see PP [0078]), a simple and predictable outcome that one of ordinary skill in the art would be able to navigate successfully.
Regarding claim 2, Jiang et al. as modified by Franer and Venskytis et al. further discloses the deformable annulus (72 in Fig. 4 of Franer) being configured to deform in response to the force applied to the seal (col. 3, lines 1-2: “The pleats (72) provide lateral pliancy so the assembly (120) can float”).
Regarding claim 3, Jiang et al. as modified by Franer and Venskytis et al. further discloses the deformable annulus (72 in Fig. 4 of Franer) comprising bellows (the pleats of 72 are bellows).
Regarding claim 4, Jiang et al. as modified by Franer and Venskytis et al. further discloses the bellows (72 in Fig. 4 of Franer) comprising a circular ridge concentric to the longitudinal axis and constrained to move orthogonally in relation to the longitudinal axis in response to the force applied to the seal (col. 3, lines 1-2: “The pleats (72) provide lateral pliancy so the assembly (120) can float”).
Regarding claim 7, Jiang et al. as modified by Franer and Venskytis et al. further discloses the deformable annulus (72 in Fig. 4 of Franer) comprising an outer perimeter fixed in relation to the elongated handle housing (col. 4, lines 18-20: “The lateral flange (74) is compressed between the retainer ring (50) and the upper body (110) to provide a seal against the housing wall”, 54 in Fig. 18 of Jiang et al., the combination as proposed would fix 74 to the housing wall of 54 of Jiang et al.).
Regarding claim 8, Jiang et al. as modified by Franer and Venskytis et al. further discloses a proximal housing portion (bottom end of 54 in Fig. 18 of Jiang et al.) comprising an annular proximal surface (55) defining a proximal end of the elongated handle housing (housing of 54), the proximal housing portion (bottom end of 54) comprising a circular opening concentric with the longitudinal axis (see opening through 55 in Fig. 24).
Regarding claim 9, Jiang et al. as modified by Franer and Venskytis et al. further discloses:
the elongated handle housing (housing of 54 in Fig. 18 of Jiang et al., the combination as proposed incorporates the seal of Fig. 1 of Franer into the housing 54 in place of 20) comprising a proximal portion (110 in Fig. 2 of Franer) configured to inhibit proximal movement of the seal (80, see MPEP 2112.01, 110 wraps around 80 to inhibit proximal movement) and a distal portion (50 in Fig. 2) configured to inhibit distal movement of the seal (80, see MPEP 2112.01, col. 2, lines 41-44: “The instrument seal assembly (120) is sandwiched between the retainer ring (50) and the upper body (110) to provide a seal at that location”),
each of the proximal and distal portions (110 and 50) respectively comprising a circular opening (see openings in Fig. 1) and a tubular extension extending distally from the respective circular opening (see Fig. 2, both 110 and 50 have height and extend distally in a tubular shape defined by their respective openings), and
each of the circular openings and the tubular extensions being concentric to the longitudinal axis (see Figs. 1-2, the openings and the respective heights/extensions of 110 and 50 are concentric to the longitudinal axis).
Regarding claim 10, Jiang et al. as modified by Franer and Venskytis et al. further discloses the rigid annulus (76 and 86 in Fig. 4 of Franer) comprising a proximal surface (upper surface of 86 in Fig. 4) configured to slide orthogonally against the proximal portion of the elongated handle housing in response the force applied to the seal (see Fig. 2, the upper surface of 86 abuts 110 via 90 and 100 and therefore slides against the proximal portion in response to applied force to 80), and comprising a distal surface (bottom surface of 76 in Fig. 4) configured to slide orthogonally against the distal portion of the elongated handle housing in response to the force applied to the seal (see Fig. 2, the lower surface of 76 fits into and slides against 50 in response to applied force to 80).
Regarding claim 21, Jiang et al. as modified by Franer and Venskytis et al. further discloses wherein the inner edge of the deformable annulus (72 in Fig. 4 of Franer) is the innermost edge of the deformable annulus (the inner edge of 72 is the innermost edge of the deformable bellows structure, this is preserved in the combination as proposed as Venskytis et al. simply provides the sandwiched rigid annulus structure).
Regarding claim 22, Jiang et al. as modified by Franer and Venskytis et al. further discloses wherein the seal (80 in Fig. 4 of Franer), the deformable annulus (72), and the rigid annulus (see 228 and 230 in Fig. 3A of Venskytis et al.) are discrete components that are separate from one another (in the combination as proposed, each component is discrete from the other as Franer provides a discrete seal and deformable annulus and Venskytis et al. provides a discrete rigid annulus, and further Venskytis et al. does not teach away from separate components).
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 Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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