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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/6/26 has been entered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-6,8,10,13,15,18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lynn et al. [US 6171287 B1, hereinafter “Lynn”].
Re. claim 1, Lynn discloses an introducer sheath assembly [Figs. 1-3] comprising:
a tubular sheath member [luer cannula 32] having a proximal end portion including a proximal end, a distal end portion terminating in a distal tip, and an internal sheath lumen extending through the proximal and distal end portions of the sheath member [Annotated Fig. 1];
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a hemostasis valve assembly [12 and 34] coupled to the proximal end of the sheath member, the hemostasis valve assembly comprising:
a housing [12] having a proximal opening [22] generally aligned with the sheath lumen to permit introduction of an instrument therethrough, the housing defining an inner surface [Annotated Fig. 1]; and
a seal member [34] positioned distal to the proximal opening [Fig. 1] to inhibit fluid leakage through the proximal opening [Col. 7 lines 30-35], the seal member comprising:
a main body portion [body of 12 except elements 72] having a proximal face, a distal face, and a peripheral surface extending between the proximal and distal faces [Annotated Fig. 1], the main body portion having a first diameter defined by the peripheral surface, the main body portion defining an access slit [41] extending from the proximal face to the distal face [Fig. 1, after penetration by cannula, see Col. 12 lines 48-50], the access slit being configured to facilitate insertion of a medical device through the seal member; and
a radial sealing feature [all elements 72, taken together] extending radially the radial projection being positioned between the proximal face and the distal face of the main body portion [Fig. 1], wherein the radial projection sealingly engages the inner surface of the housing [Fig. 1].
Re. claim 10, Lynn discloses the hemostasis valve assembly as set forth with respect to claim 1 above, including the seal member configured to inhibit fluid leakage as set forth above [Col. 7 lines 30-35].
Re. claim 15, Lynn discloses the hemostasis seal member as set forth with respect to claim 1 above, including the seal member having a generally cylindrical main body [Figs 1 and 2).
Re. claims 4, 13, and 18, Lynn discloses the radial projection has first and second side faces extending radially from the peripheral surface, and a perimeter face extending from the first side face to the second side face [annotated fig 1 excerpt below].
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Re. claim 5, Lynn discloses the radial projection has an outer surface that extends from the peripheral surface at an oblique angle relative to a longitudinal axis extending through and perpendicular to the proximal and distal faces [annotated fig 1 excerpt below].
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Re. claims 6 and 19, Lynn discloses the radial sealing feature comprises a plurality of spaced radial projections [Fig. 1] each extending radially outward of and circumferentially about the peripheral surface of the main body [Fig. 1], wherein each radial projection is in sealing engagement with the inner surface of the housing [Fig. 1].
Re. claim 8, Lynn discloses each radial projection has first and second side faces extending radially from the peripheral surface, and a perimeter face extending from the first side face to the second side face as set forth [see Fig. 1; claim 4 above]
Re. claim 20, Lynn discloses the radial sealing feature further comprises a concave recess [78] extending radially inward from the peripheral surface [Fig. 1], the concave recess having a cross-sectional profile capable of receiving receive an annular projection of the housing in sealing engagement therewith [the housing is not a positively recited part of the invention of claim 20, so its structure does not provide patentable distinction].
Claim(s) 9, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynn, embodiment in Fig. 17.
Re. claims 1, 10, Lynn discloses the apparatus of claims 1, 10 in Fig. 17 (same mapping as the above claim 1, except that the radial projection and cooperating portion of the housing differ in shape [see annotated Fig. 17 below]).
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Re. Claims 9, 14: Lynn further discloses, in the embodiment of Fig. 17, the inner surface of the housing includes an annular projection [182], and wherein the radial sealing feature further comprises a concave recess extending radially inward from the peripheral surface [the recess cooperating with the projection], the concave recess having a cross-sectional profile configured to receive the annular projection of the housing in sealing engagement therewith [at least when the projection is inserted, Fig. 17].
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) 3, 7, 12, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynn (embodiment of Fig. 1) in view of Durgom [US Pat. 3317214].
Re. Claims 3, 12, and 17: Lynn fails to teach the semicircular profile. However, forming a seal projection to have a semicircular cross sectional profile is taught by Durgom [Fig. 2]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lynn by forming the radial projection to have a semicircular cross sectional profile as taught by Durgom because this configuration has “proven effective both in providing satisfactory sealing action and in stabilizing the gasket cross sectional shape during assembly,” Durgom Col. 3 lines 43-48].
Re. claim 7, Lynn-Durgom teaches the apparatus substantially as set forth with respect to claims 6, 7, and 3 above. Forming both projections to have the same shape would have been obvious in light of the above references.
Response to arguments
Applicant’s arguments dated 1/6/26 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/ Primary Examiner, Art Unit 3771