Patent AU-2012200018-B2 (AU)
Title: Vascular access device
Inventor: TAL MICHAEL
IPC: A61B17/32
Filed: 2012-01-03
Granted: 2013-11-21
Abstract: Om: To:epo munich 2310912011 18:46 #709 P.006/007 PG431905EPA 1. A vascular access device, the device comprising: a hollow needle (180) having a sharpened distal tip and defining a side hole (182) proximal to the distal tip; a guidewire (204) preloaded in the needle; a dilator (184) coaxially mounted on the needle; and a sheath (196) coaxially mounted on the dilator (184); wherein an annular space is defined between the needle and the dilator, in the dilator, and additionally or alternatively by the sheath, the annular space being in communication with the needle bore through the side hole, and the dilator (184) has one or more small openings, pores, or porous material to allow air or gas to escape but retain blood, wherein at least one of the dilator (184) and sheath (196) is clear, semi opaque, or translucent, so that blood, if any, in the annular space, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a body location. 2. A device as defined by claim 1, wherein the sheath (196) is provided with one or more small openings, pores, or porous material to allow air or gas to escape but retain blood. 3. A device as defined by any preceding claim, wherein the dilator (184) can be advanced distally over the needle (180) to a position in which it covers the sharpened distal tip of the needle. 4. A device as defined by any preceding claim, wherein the dilator (184) is clear, semi-opaque, or translucent. 5. A device as defined by any preceding claim, wherein the annular space is defined between the dilator and the sheath and the dilator comprises an opening allowing communication between the needle and the sheath. 5010369-i-mmcpherson rom: To:epo munich 2310912011 18:46 #709 P.007/007 PG431905EPA 6. A device as defined by Claim 5, wherein the dilator comprises a continuous tube structure (114), so that the annular space is defined between the sheath and the dilator, and so that blood, if any, in the space, may be visualized through the dilator and the sheath to confirm proper placement of the needle in the blood vessel. 7, A device as defined by any of Claims I to 4, wherein the annular space is defined between the dilator and the needle. 8. A device as defined by any preceding claim, wherein the sheath comprises a port (178) allowing blood to be aspired through a syringe. 9. A device as defined by any preceding claim, where the sharpened distal tip of the hollow needle (180) protrudes distally from the dilator (184) by a length sufficient to reach a central blood vessel of a patient without the dilator contacting the skin of the patient. 10. A device as defined by any preceding claim, wherein the sheath comprises a hemostatic valve to prevent blood flow out the distal end of the sheath. 11. A device as defined by any preceding claim, wherein the needle can be retracted into the dilator and locked in place. 12. A device as defined by any preceding claim, wherein the needle comprises a twist lock member. 50810359-1-mmepherson From. To:epo munich 23/09/2011 18:45 #709 P.001/007 Marks&Clerk LLP Patent and Trade Mark Attorneys Glasgow Office 120 Bothwell Street, Glasgow G2 7JS Tel: +44 (0)141 221 5757 Fax: +44 (0)141 221 7739 glasgow@marks-clerkocom www.marks-clerk.com European Patent Office Gitschiner Strasse 103 Berlin Germany Our Ref: MMP/MGH/PG431905EPA Date: 23 September 2011 By Fax only - to EPO Munich Dear Sirs European Patent Application No 10002041.1 In the name of Yale University in response to the communication of 15 July 2011 noting loss of rights pursuant to Rule 112(1) EPC we hereby request Further Processing. The fee for further processing is being paid separately, today. Below we respond to the opinion accompanying the European Search Report, thus completing the omitted act. In response to the search opinion the applicant makes the following amendments to the claims and provides comments thereon. In the Claims Claims 1 to 15 previously pending are deleted and replaced with claims 1 to 12 attached to this letter. Claim 1 is amended to now be directed to a vascular access device wherein "an annular space is defined between the needle and the dilator, in the dilator, and additionally or alternatively by the sheath, the annular space being in communication with the needle bore through the side hole, and the dilator (184) has one or more small openings, pores, or porous material to allow air or gas to escape but retain blood, wherein at least one of the dilator (184) and sheath (196) is clear, semi-opaque, or translucent, so that blood, if any, in the annular space, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a body location." Basis for this amendment can be found at page 2, lines 16 to 24 of the application as filed together with the passages at page 8, lines 4 to 24 and the figures described therein. Further support can be found for example in the description of particular features provided in the detailed description of the invention and the other figures described therein. In particular the vascular access device now has an annular space defined between the needle and dilator, in the dilator, and additionally or alternatively by the sheath as described in the passage referred to in page 2 mentioned above. Marks & Clerk LLP is a limited liability partnership and is 'egistered in England and Wales with registered number 00343273, A list of members names is open to npectlo at ogr egiatered ofrio, 90 Long Acre. London WC2E ORA Tne frrr is regulated by the tillectua Proerty gulti Board OPREG) d Marks & Cleork ILK OttiCcs~ Abetreer Birrirh~r Carnibridge Cheltenham Edinburgh Glasgow Leeds Leicester London Manchester Otord Marks & Clerk affiliated overseas firms have offices in the following locations: Luxembourg Parls Hong Kong Kuiala Lumpir Singapore ODijing Sharghai Ottawa 50854959-1-mmopherson From: To:epo munich 23/09/2011 18:46 #709 P.002/007 -2 Similarly a feature of the dilator having one or more small openings, pores, or porous material to allow air or gas to escape but retain blood is found at page 8, lines 12 to 16. Claims 2, 4, and 5 are deleted and the remaining claims renumbered and their dependencies altered accordingly. Claim 2 (previously 3) is amended to be directed to the situation where the sheath is provided with one or more small openings, pores, or porous material to allow air or gas to escape but retain blood. Basis for this amendment can be found at page 8, lines 12 to 16 where it is explained that the one or more small openings, pores, or porous material may be provided in the sheath as an example of location, in addition to on the dilator. Claim 3 (previously 6) had been amended in response to the examiner's objection to use the language "wherein the dilator can be advanced distally" in accordance with the description at page 3, lines 8 to 10. Claim 5 (previously 8) is amended to the option where the annular space is defined between the dilator and the sheath and adds the feature that the dilator comprised an opening allowing communication between the needle and the sheath. This can be found for example in the embodiment of figure 3 as well as the situation in figure 5 where the annular space provided by the hollow distal section 186 of the dilator is in communication with the annular space provided between the needle 180 and the sheath 196. Claims 6 and 7 (previously 9 and 10) are amended to specifically recite that the space is an annular space. Claim 8 (previously 11) is amended in response to the examiner's objection to be direct to the situation wherein the sheath comprises a port allowing blood to be aspired through a syringe. This amendment finds basis at page 7, lines 20 to 21 and page 2, lines 23 to 24 of the application as filed. Double Patentina The applicant thanks the examiner for pointing to potential problems of double patenting. Independent claim 1 is now directed to the situation where the dilator is provided with one or more small openings, pores, or porous material to allow air or gas to escape but retain blood, in contrast to the parent application where the venting is provided by openings, pores, or porous material on the sheath. Article 76 (1) EPC and Artcle 84 EPC The amendments to the claims described above remove the objection to passages in the previously pending claims, especially claim 1. In particular the term "passage" has been removed and where space is referred to it is referred to as being an annular space as supported by the application as originally filed, It is therefore submitted that the objections on the basis of Article 76 (1) EPC are removed. As far as the objection under Article 84 is concerned, as discussed above, the term "passage" has been removed. The examiner also suggested that claim 1, as previously pending, was not supported by the description. The applicant respectfully submits that the claims as now amended do not constitute an intermediate generalisatlon. In the summary of the invention passage at page 2, lines 16-24 an annular space Is described. Various 50854959-1-mmcpherson From: To:epo munich 23/09/2011 18:46 #709 P.003/007 -3 drawings and the discussions thereon show a number of different ways in which the annular space may be provided, in some cases two annular spaces are provided for, but this is not necessarily a requirement. See for example figures 6 and 7 wherein dilators with essentially solid end pieces are employed which when combined with the sheath would result in singular annular space being provided between the needle (232) and the sheath. The examiner has also asked that the claims be provided In the two part form, but this would lengthen and introduce additional complexity to the claims contrary to Art 84 and therefore the applicant respectfully asks that they be maintained in their present form. Novelty and Inventive Step The examiner suggested that the claims before amendment were not new with respect to DI. It is re