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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6-7 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 6, 7, and 20 are unclear as to the scope of how the seal is being modified. They appear to be simply claiming basic material properties in a sort of method or production step. Are the cross-sections being actively increased or decreased in thickness? It’s unclear how this could happen after production and installation of the seal to change the movement or resistance of various parts of the seal as claimed. It is not appropriate to claim a limitation in the manner “if something about the element changes it will have an effect….” If there is some structural feature that is intended to be varied in some dimension and which would lead to unexpected results regarding how the element functions, the claims should be drafted to clarify this. At this time, it is unclear what the claims are attempting to set forth apart from the general expected nature of such changes. The claims will be examined as if the seal dimensions are simply hypothetical and a function of their elastomeric properties since no actual scope can be reasonably determined.
Claim Rejections - 35 USC § 102
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) 1 and 4-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okoniewski (US 2009/0024097).
Regarding claim 1, Okoniewski discloses a hemostatic seal (seal cover 206; Figures 1-3) for use in a transcatheter delivery systems or vascular sheath access system (see e.g., ¶ [0003]), the hemostatic seal comprising: an outer portion (see annotated Figure 2 below) with a first cross-section thickness; an inner annular portion with a second cross-section thickness (see annotated Figure 2 below; the seal area around opening 212 is of larger cross-section than the wall thickness of the portion connecting the inner seal portion to the outer seal portion); and a thin web portion with a third cross-section thickness (see annotated Figure 2 below), the thin web portion connecting the inner annular portion to the outer portion, wherein the first cross-section thickness is greater than the second cross-section thickness and the second cross-section thickness is greater than the third cross-section thickness (it can be seen in annotated Figure 2 below that the outer edge of the seal comprises the longest cross-section, the inner seal portion surrounding 212 comprises the second longest cross-section, and the connecting web portion comprises a wall thickness which is less than both the first and second thicknesses as claimed).
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Regarding claim 4, Okoniewski further discloses wherein the inner annular portion (at 212) forms a central hole through which a delivery device is configured to pass (¶ [0043]).
Regarding claim 5, Okoniewski further discloses wherein passing a delivery device through the inner annular portion causes the inner annular portion to move relative to the outer portion (there will be some deflection of the inner seal portion as the instrument is passed through opening 212 due to friction of the instrument on the walls of the inner annular portion; at least some stretching or expansion will occur depending on the diameter of the instrument relative to the opening; it is intended to be a tight fit with the instrument so there will be some frictional engagement).
Regarding claims 6-7, Okoniewski further discloses wherein increasing the third cross-section thickness reduces movement of the inner annular portion responsive to passing the delivery device through the inner annular portion (it is apparent that increasing the wall-thickness dimension of the web portion would increase the force required to deflect the central seal portion as an instrument is passed through; this is due to basic material properties); or wherein increasing the second cross-sectional thickness increases resistance of the inner annular portion to radial expansion (again, increasing the central annular thickness will make it more difficult for an instrument to expand opening 212 since there is more material to deflect).
Regarding claim 8, Okoniewski further discloses wherein the outer portion has a substantially circular cross-section (Figures 1-3).
Regarding claim 9, Okoniewski further discloses wherein the inner annular portion has a substantially circular cross-section (Figures 1-3).
Regarding claim 10, Okoniewski further discloses wherein the third cross-section thickness is substantially uniform between the outer portion and the inner annular portion (Figures 1-3, the wall thickness of the middle portion is generally uniform; the thickness of the area being designated as the third portion in the annotated figure above is uniform along that section; the claim does not prevent selecting an arbitrary section of the web; the claim does not require constant web thickness from the outer portion to the inner annular portion).
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okoniewski in view of Dennis (US 2002/0013552).
Regarding claim 2, Okoniewski discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose wherein the outer portion, the inner portion, and the thin web portion are made from a single, unitary piece of material (see Figures 1-3; the seal appears unitary but there is no explicit disclosure that it is).
Dennis teaches that it is know to form a medical seal element as a monolithic, unitary element (¶ [0026] discloses forming the seal as a unitary assembly).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the seal of Okoniewski to be formed as a unitary component since Dennis teaches that the forming of such seals as single elements is known in the art and would maintain the function of the seal of Okoniewski to receive medical instruments in a fluid-tight manner.
Regarding claim 3, Okoniewski teaches the use of elastomeric materials for the seal body (see e.g., ¶ [0030] which discloses that the substrates such as the seals may be elastomeric), but does not explicitly disclose the elastomer as low durometer.
Dennis further teaches wherein the seal is formed from a low durometer elastomer (e.g., silicone as in ¶ [0028] and which material is used as an example of a low durometer elastomer in the instant disclosure at ¶ [0033]).
It would have been obvious to one of ordinary skill in the art at the time of filing to form the seal of Okoniewski out of a low durometer elastomer such as the silicone disclosed by Dennis since Dennis teaches that such a material is known for use in medical seals and valves for engaging instruments in a fluid-tight manner (e.g., instrument through bore 20; ¶ [0021]).
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hart et al. (US 8,147,458) in view of Okoniewski.
Regarding claim 11, Heart et al. (henceforth Heart) discloses a medical device system comprising an access sheath (10) having a tubular shaft (27; Figure 1); a hub (24; Figure 1), and first seal (seal 45; Figure 1; Col. 5, lines 22-35). Heart fails to explicitly disclose the claimed configuration of the first seal.
Okoniewski teaches a hemostatic seal (seal cover 206; Figures 1-3) for use in a transcatheter delivery systems or vascular sheath access system (see e.g., ¶ [0003]), the hemostatic seal comprising: an outer portion (see annotated Figure 2 above) with a first cross-section thickness; an inner annular portion with a second cross-section thickness (see annotated Figure 2 below; the seal area around opening 212 is of larger cross-section than the wall thickness of the portion connecting the inner seal portion to the outer seal portion); and a thin web portion with a third cross-section thickness (see annotated Figure 2 above), the thin web portion connecting the inner annular portion to the outer portion, wherein the first cross-section thickness is greater than the second cross-section thickness and the second cross-section thickness is greater than the third cross-section thickness (it can be seen in annotated Figure 2 above that the outer edge of the seal comprises the longest cross-section, the inner seal portion surrounding 212 comprises the second longest cross-section, and the connecting web portion comprises a wall thickness which is less than both the first and second thicknesses as claimed). Okoniewski fails to explicitly disclose a second seal, the sheath, the tubular shaft, and the hub.
It would have bene obvious to one of ordinary skill in the art at the time of filing to modify the trocar system of Hart to comprise the annular seal of Okoniewski since the seal of Okoniewski provides the same function as seal 45 of Hart. Okoniewski teaches that it is known to use annular seals comprising the claimed relative dimensions to receive medical instruments in a fluid-tight manner and therefore one of ordinary skill in the art would have found it obvious to use a seal with such a configuration to perform the same function in the device of Hart.
Regarding claim 12, Hart discloses that the first hemostatic seal is removable positioned at a proximal portion of the hub (see Figure 1, seal 45 as modified by Okoniewski is located at a proximal end of the device).
Regarding claim 13, Hart further discloses the use of a second seal (60; Figure 1; Col. 5, lines 42-53).
Regarding claim 14, Hart further discloses wherein the second hemostatic seal (60) is adjacent to the first hemostatic seal (Figure 1).
Regarding claim 15, Hart fails to explicitly disclose wherein the second hemostatic seal comprises the same relative dimensions as the first seal. However, it would have been obvious to one of ordinary skill in the art at the time of filing to utilize the seal of Okoniewski as both the first and second seal in the device of Hart. Hart contemplates the first and second seals being used to receive instruments of different diameters. In this manner, the second seal of Okoniewski could replace seal 45 of Hart having a slightly smaller diameter than the first seal to receive instruments of smaller diameter in a fluid-tight manner without affecting the function of the larger first seal; this maintains the intended use of the device of Hart (e.g., Col. 5, lines 42-53). Such a modification would have been obvious to one of ordinary skill in the art at the time of filing especially since it would maintain the original function of the device of Hart.
Regarding claim 16, Hart/Okoniewski teach the claimed invention substantially as set forth above for claim 11, and Hart further discloses that at least one seal is monolithic (claim 10 explicitly discloses that seal 45 is monolithic as claimed).
Regarding claim 17, Okoniewski further teaches wherein the third cross-section thickness is substantially uniform between the outer portion and the inner annular portion (Figures 1-3, the wall thickness of the middle portion is generally uniform; the thickness of the area being designated as the third portion in the annotated figure above is uniform along that section; the claim does not prevent selecting an arbitrary section of the web; the claim does not require constant web thickness from the outer portion to the inner annular portion).
Regarding claim 18, Okoniewski further discloses wherein the inner annular portion (at 212) forms a central hole through which a delivery device is configured to pass (¶ [0043]).
Regarding claim 19, Okoniewski further discloses wherein passing a delivery device through the inner annular portion causes the inner annular portion to move relative to the outer portion (there will be some deflection of the inner seal portion as the instrument is passed through opening 212 due to friction of the instrument on the walls of the inner annular portion; at least some stretching or expansion will occur depending on the diameter of the instrument relative to the opening; it is intended to be a tight fit with the instrument so there will be some frictional engagement).
Regarding claim 20, Okoniewski further discloses wherein increasing the third cross-section thickness reduces movement of the inner annular portion responsive to passing the delivery device through the inner annular portion (it is apparent that increasing the wall-thickness dimension of the web portion would increase the force required to deflect the central seal portion as an instrument is passed through; this is due to basic material properties); or wherein increasing the second cross-sectional thickness increases resistance of the inner annular portion to radial expansion (again, increasing the central annular thickness will make it more difficult for an instrument to expand opening 212 since there is more material to deflect).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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