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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the irregular geometry must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 31, 33, 36, 39, 44, 46, and 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roudy (FR 2631835).
With regard to claims 31 and 33, Roudy teaches an access sleeve comprising: a sleeve body extending along a longitudinal axis of the access sleeve, the sleeve body having first and second open ends, wherein the sleeve body comprises an inner surface including at least one recess extending between the first and second open ends of the sleeve body (Fig. 1 member 2 open ends on either side of L, recess 6); a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body (Figs. 1 and 2 lumen within 2); and a lateral opening in the sleeve body connecting the first lumen to an outer surface of the sleeve body, the lateral opening extending from the first open end to the second open end, wherein the lateral opening is expandable and configured to enable attachment of the access sleeve to a medical device between a first end and a second end of the medical device such that the medical device becomes housed within the first lumen (Fig. 2 opening 3, Fig. 4 shows 2 around a medical device).
With regard to claim 35, the recess receives 5 (Fig. 6A).
With regard to claims 36 and 39, there is necessarily a tip, the inner diameter is constant.
With regard to claims 44 and 46, Roudy teaches an access system comprising: a medical device configured for insertion into an arteriotomy of a patient, the medical device having a first end and a second end (Fig. 3 member 8, see translation Pgs. 4 and 6 may be used in an artery); and an access sleeve comprising: a sleeve body extending along a longitudinal axis of the access sleeve, the sleeve body having first and second open ends, wherein the sleeve body comprises an inner surface including at least one recess extending between the first and second open ends of the sleeve body (Fig. 1 member 2 open ends on either side of L, recess 6), a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body (Figs. 1 and 2 lumen within 2), and a lateral opening in the sleeve body connecting the first lumen to an outer surface of the sleeve body, the lateral opening extending from the first open end to the second open end, wherein the lateral opening is expandable and configured to enable attachment of the access sleeve to the medical device between the first end and the second end of the medical device such that the medical device becomes housed within the first lumen (Fig. 2 opening 3, Fig. 4 shows 2 around a medical device).
With regard to claim 48, the recess receives 5 (Fig. 6A).
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) 32 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roudy (FR 2631835) as applied to claims 31 and 44 above, and further in view of Jelle et al. (US 2017/0281907 A1).
With regard to claims 32 and 45, Roudy teaches a device substantially as claimed but does not teach an irregular geometry to minimize contact. However. Jelle et al. teach using ridges on the inner surface of a sheath to minimize surface contact and reduce friction ([0036]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use irregular geometry in Roudy as Jelle et al. teach it is beneficial to reduce friction.
Claim(s) 34 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roudy (FR 2631835) as applied to claims 31 and 44 above, and further in view of Lampropoulos et al. (US 5,817,072).
With regard to claims 34 and 47, Roundy teaches two arms on either side of the opening (Fig. 2) but does not specifically show rounded edges. However, Lampropoulos et al. teach a slit with tapered rounded edges so that the sleeve has les trauma and may seal better around an instrument (Fig. 8 and 69 and 69’, Col. 10 lines 19-24). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use rounded edges in Roundy as Lampropoulos et al. teach this is beneficial for sealing and reducing trauma.
Claim(s) 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roudy (FR 2631835) as applied to claims 31 above, and further in view of Little et al. (US 2014/0275795 A1).
With regard to claims 37 and 38, Roudy teaches a device substantially as claimed but does not disclose a tapered tip. However, Little et al. teach an introducer in which the inner diameter may be constant or tapered and the tip may be tapered to reduce trauma and vessel damage and allow for easy withdrawal ([0101], Figs. 21-24). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to taper the tip of Roudy as Little et al. teach such to be an art effective equivalent and beneficial for reducing damage and allowing for withdrawal.
Claim(s) 40-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roudy (FR 2631835) and Little et al. (US 2014/0275795 A1) as applied to claim 31 above, and further in view of Horrigan et al. (US 5,792,124).
With regard to claims 40-43, Roudy teaches a device substantially as claimed. Roudy as combined with Little et al. do not disclose the materials of the body and tip as recited. However, Little et al. teach tubing inserted into the vasculature in which the tip is softer than the body so that it does not damage the body while still being able to be controlled (Col. 1 lines 13-25). The body many be made of a harder Pebax while the tip is a softer elastomer (Col. 4 lines 30-40). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use materials as recited for the body and tip of Roudy as combined with Little et al. as Horrigan et al. teach this is beneficial for preventing damage while still maintaining control.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roudy (FR 2631835) as applied to claim 44 above, and further in view of Horrigan et al. (US 5,792,124).
With regard to claim 49, Roudy teaches a device substantially as claimed. Roudy does not disclose the material of the body as listed. However, Little et al. teach tubing inserted into the vasculature in which the tip is softer than the body so that it does not damage the body while still being able to be controlled (Col. 1 lines 13-25). The body many be made of a harder Pebax while the tip is a softer elastomer (Col. 4 lines 30-40). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use materials as recited for the body and tip of Roudy as Horrigan et al. teach this is beneficial for preventing damage while still maintaining control.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roudy (FR 2631835) as applied to claim 44 above, and further in view of Corbett et al. (US 2017/0049947 A1).
With regard to claim 50, Roudy teaches the device may be one of various cardiac implements (Pg. 6 4th full paragraph) but do not disclose a heart pump. However, Corbett et al. teach a percutaneous pump is inserted in the vasculature via an introducer sheath ([0005]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use the device of Roudy with a percutaneous pump as in Corbett et al. as Roudy is for delivering various devices into the vasculature and Corbett et al. teach such is an art effective treatment device delivered through a sheath.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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