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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitation of “an outer surface of the medical device is exposed within the antechamber” is not present in the application as originally filed. The examiner notes that the limitation is negative in nature and as such generally explicit support is required to demonstrate possession. See MPEP 2173.05(i).
Regarding claim 11, the limitation of “an outer surface of the medical device is uncovered within the interior of antechamber[sic]” is not present in the application as originally filed. The examiner notes that the limitation is negative in nature and as such generally explicit support is required to demonstrate possession.
Regarding claim 17, the limitation of “the antechamber is free of a tubular body extending therein between the first hemostasis valve and the second hemostasis valve” is not present in the application as originally filed. The examiner notes that the limitation is negative in nature and as such generally explicit support is required to demonstrate possession. Additionally, it is unclear how the medical device is not a “tubular body” extending as claimed.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 10,500,349 to Shivkumar et al. (Shivkumar hereinafter) in view of US Pre-Grant Publication 2002/0111585 to Lafontaine (Lafontaine).
Regarding claim 1, Shivkumar teaches an introducer assembly (see e.g. Fig. 11) comprising an introducer body (504) adapted to accommodate a volume of fluid therein, an antechamber (1104) therein, a first hemostasis valve (1130) and a second hemostasis valve (506) respectively disposed proximal of and distal of the antechamber and adapted to allow a medical device (904) to pass therethrough (col. 12, ln. 33-60), the first communicating the introducer body with the antechamber. Shivkumar further teaches that the antechamber is filled with liquid such as saline (see e.g. col. 11, ln. 14-27) and that any air trapped therein can be drawn out through the associated check valve 1112 (col. 11, ln. 39-42). Further, Shivkumar teaches that the introducer body is also filled with liquid such as saline (col. 11, ln. 1-13) and that any air therein may be drawn out through the associated check valve (512). Taken together with the teaching that the valves of Shivkumar define the introduction path and bound the wet portion of the apparatus, Shivkumar teaches a wet path passing sequentially through the first hemostasis valve (1130), the antechamber, and the second hemostasis valve (506), and that it is substantially filled with saline providing a continuous liquid interface for the medical device. As best understood, an exterior, or outer, surface of the medical device (904) is exposed (e.g. to the saline) within the antechamber. Shivkumar is silent to valve structure, including an annular groove and a spring. Lafontaine teaches a hemostasis valve generally, and particularly teaches that a spring (230) may be provided in an annular groove (between 228 and 222, see Figs. 8A and 8B). Lafontaine teaches that this allows the valve to be manually activated and inactivated (paragraph 35). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a hemostasis valve as taught by Lafontaine to the introducer assembly of Shivkumar in order to provide a manually controllable valve assembly.
Regarding claims 2 and 18, Shivkumar as modified in view of Lafontaine teaches the limitations of claims 1 and 17 from which these claims depend, but does not explicitly teach annular chambers having the claimed major and minor axes. However, the examiner notes that applicant has not established any particular criticality to these limitations. The examiner further notes that where the difference between the prior art and the claimed invention is a matter of shape, there is no patentable distinction absent evidence that the shape is significant (MPEP 2144.04 IV. B). Accordingly, since Shivkumar teaches an axis of introduction (e.g. right to left in Fig. 11), the only difference between the prior art and the claimed invention is a shape for which there is not persuasive evidence of criticality. The examiner notes that applicant has specifically noted that changes in shape are possible (paragraph 51 of applicant’s specification). The examiner therefore concludes that these claims are obvious over Shivkumar as, at most, a change in shape that does not rise to the level of patentability.
Regarding claims 3, 6-7 and 19, Shivkumar teaches that the axis of introduction extends as claimed (see Fig. 11, axis of introduction extending through the centers of 504 and 1104 from right to left).
Regarding claims 4 and 20, Shivkumar teaches that the major axis is vertical to allow air to rise to the relevant valve (see Fig. 10, col. 10, ln. 47-55) and the level of saline is sufficient to enforce the rising action.
Regarding claim 8, Shivkumar teaches luer fittings (512, 514, 1112) disposed at different locations relative to the periphery of the antechamber, and thus disposed about the periphery.
Regarding claim 9, Shivkumar teaches that the luer fittings are adapted to be used to introduce saline into the antechamber, for instance via the use of a catheter similar to the catheter (904, Fig. 11).
Regarding claim 10, Shivkumar teaches that one of the luer fittings (1112) is adapted to bleed air out of the antechamber (col. 14, ln. 1-2).
Regarding claims 5 and 12, as noted above, Shivkumar teaches that the antechamber is filled with liquid such as saline (see e.g. col. 11, ln. 14-27) and that any air trapped therein can be drawn out through the associated check valve 1112 (col. 11, ln. 39-42) such that the wet path will be submerged.
Regarding claim 11, Shivkumar teaches an introducer assembly (see e.g. Fig. 11) comprising an introducer body (504) adapted to accommodate a volume of fluid therein, an antechamber (1104) therein, a first hemostasis valve (1130) and a second hemostasis valve (506) respectively disposed proximal of and distal of the antechamber and adapted to allow a medical device (904) to pass therethrough (col. 12, ln. 33-60), the first communicating the introducer body with the antechamber. Shivkumar further teaches that the antechamber (1104) is adapted to hold a volume of saline sufficient to submerge a path along which the medical device (904) may travel and to permit air to be purged. The examiner notes that adaptation to hold liquid requires only a solid surface or a surface with all but one opening being sealable. Shivkumar further teaches that the antechamber is filled with liquid such as saline (see e.g. col. 11, ln. 14-27) and that any air trapped therein can be drawn out through the associated check valve 1112 (col. 11, ln. 39-42). Further, Shivkumar teaches that the introducer body is also filled with liquid such as saline (col. 11, ln. 1-13) and that any air therein may be drawn out through the associated check valve (512). Taken together with the teaching that the valves of Shivkumar define the introduction path and bound the wet portion of the apparatus, Shivkumar teaches a wet path passing sequentially through the first hemostasis valve (1130), the antechamber, and the second hemostasis valve (506), and that it is substantially filled with saline providing a continuous liquid interface for the medical device. As best understood, an exterior, or outer, surface of the medical device (904) is uncovered (e.g. with respect to the saline) within the antechamber. Furthermore, Shivkumar teaches a wet path passing sequentially through the first hemostasis valve (1130), the antechamber, and the second hemostasis valve (506), and that it is substantially filled with saline providing a continuous liquid interface for the medical device. Shivkumar is silent to valve structure, including an annular groove and a spring. Lafontaine teaches a hemostasis valve generally, and particularly teaches that a spring (230) may be provided in an annular groove (between 228 and 222, see Figs. 8A and 8B) and having an annular recess for receiving a spacer (224). Lafontaine teaches that this allows the valve to be manually activated and inactivated (paragraph 35). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a hemostasis valve as taught by Lafontaine to the introducer assembly of Shivkumar in order to provide a manually controllable valve assembly.
Regarding claim 13, Shivkumar teaches purging of air (via 1112).
Regarding claim 14, Shivkumar teaches luer fittings (512, 514, 1112) disposed at different locations relative to the periphery of the antechamber, and thus disposed about the periphery.
Regarding claim 15, Shivkumar teaches that the luer fittings are adapted to be used to introduce saline into the antechamber, for instance via the use of a catheter similar to the catheter (904, Fig. 11).
Regarding claim 16, Shivkumar teaches that one of the luer fittings (1112) is adapted to bleed air out of the antechamber (col. 14, ln. 1-2).
Regarding claim 17, Shivkumar teaches an introducer assembly (see e.g. Fig. 11) comprising an introducer body (504) adapted to accommodate a volume of fluid therein, an antechamber (1104) therein, a first hemostasis valve (1130, attached to a proximal cylindrical portion upstream thereof) and a second hemostasis valve (506, attached to a distal cylindrical portion upstream thereof) respectively disposed proximal of and distal of the antechamber and adapted to allow a medical device (904) to pass therethrough (col. 12, ln. 33-60), the first communicating the introducer body with the antechamber. Shivkumar further teaches that the antechamber (1104) is adapted to hold a volume of saline sufficient to submerge a path along which the medical device (904) may travel and to permit air to be purged. The examiner notes that adaptation to hold liquid requires only a solid surface or a surface with all but one opening being sealable, which constitutes an outer shell defining a passageway. Shivkumar further teaches that the antechamber is filled with liquid such as saline (see e.g. col. 11, ln. 14-27) and that any air trapped therein can be drawn out through the associated check valve 1112 (col. 11, ln. 39-42). Further, Shivkumar teaches that the introducer body is also filled with liquid such as saline (col. 11, ln. 1-13) and that any air therein may be drawn out through the associated check valve (512). Taken together with the teaching that the valves of Shivkumar define the introduction path and bound the wet portion of the apparatus, Shivkumar teaches a wet path passing sequentially through the first hemostasis valve (1130), the antechamber, and the second hemostasis valve (506), and that it is substantially filled with saline providing a continuous liquid interface for the medical device.
Claim(s) 2-4, 6-7, 11-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shivkumar in view of Lafontaine as applied to claims 1 and 17 and further in view of in view of U.S. Patent 9,078,981 to Subramaniam et al. (Subramaniam).
Regarding claims 2-3, 11, and 18-19, Shivkumar as modified by Lafontaine teaches the limitations of claim 1 from which claim 2 depends, but does not explicitly teach that the antechamber has an annular body with a major and minor dimension, the major dimension being perpendicular with an axis of insertion (i.e. path of 904 in Shivkumar). Subramaniam teaches another medical device generally, and particularly teaches that an antechamber (105) may have an annular body (130) with a major dimension perpendicular to the insertion axis (MD). Subramaniam teaches that this allows for inhibition of gas infiltration (col. 2, ln. 6-32). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an annular body as taught by Subramaniam either instead of or in addition to the antechamber of Shivkumar in order to assist in preventing gas infiltration.
Regarding claims 4, 12, Shivkumar teaches that the antechamber (1104) is adapted to hold a volume of saline sufficient to submerge a path along which the medical device (904) may travel and to permit air to be purged. The examiner notes that adaptation to hold liquid requires only a solid surface or a surface with all but one opening being sealable.
Regarding claims 6-7, Shivkumar teaches that the axis of introduction extends as claimed (see Fig. 11, axis of introduction extending through the centers of 504 and 1104 from right to left).
Regarding claim 13, Shivkumar teaches that one of the luer fittings (1112) is adapted to bleed air out of the antechamber (col. 14, ln. 1-2) upon entry of sufficient saline.
Regarding claim 14, Shivkumar teaches luer fittings (512, 514, 1112) disposed at different locations relative to the periphery of the antechamber, and thus disposed about the periphery.
Regarding claim 15, Shivkumar teaches that the luer fittings are adapted to be used to introduce saline into the antechamber, for instance via the use of a catheter similar to the catheter (904) of Fig. 11.
Regarding claim 16, Shivkumar teaches that one of the luer fittings (1112) is adapted to bleed air out of the antechamber (col. 14, ln. 1-2).
Regarding claim 20, Shivkumar teaches that the major axis is vertical to allow air to rise to the relevant valve (see Fig. 10, col. 10, ln. 47-55) and the level of saline is sufficient to enforce the rising action.
Response to Arguments
Applicant's arguments filed 8 July 2026 have been fully considered but they are not persuasive.
With respect to the new matter, to any extent which the limitations regarding exposure of the outer surface of a medical device are proposed to exclude structure present in Shivkumar, they are negative limitations. Presentation of an example which does not include a feature is not sufficient basis for disclaiming that feature. The new matter rejection is therefore maintained.
With respect to the new limitations, the examiner cites herein to Lafontaine as teaching the details of a hemostasis valve which falls into the scope defined by the claimed invention.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 10 September 2026
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