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 § 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) 11-21 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lepulu et al (US 6,533,770).
The claims are product-by-process – MPEP 2113(I). Such that patentability is based on the product itself, not dependent on its method of production (only on structure the method results in).
Regarding claim 11, Lepulu discloses a cannula (figs 25-33) configured to facilitate delivery of medicament to a user formed by a process comprising: arranging a plurality of coils on a mandrel (coil described in Col.20 ll 10 and seen as a plurality in figs 28-33; the mandrel does not give any specific structure and the plurality of coils of Lepulu are indistinguishable from those claimed); providing a spacer 398 on the mandrel between each of the coils to form an assembly having alternating coils and spacers along the mandrel (figs 28-30, again, the mandrel does not give any specific structure and the plurality of coils of Lepulu are indistinguishable from those claimed); processing the assembly through an extrusion device to form an outer tube 402 around the assembly (Col.21 ll 6-19; outer tube is shown, extrusion device does not convey any specific structure such that Lepulu is indistinguishable from the device made by the claimed method); cutting the processed assembly adjacent both ends of each coil to create a plurality of cannula sections (fig 27, the cutting does not convey any specific structure such that Lepulu is indistinguishable from the device made by the claimed method); and forming a cannula configured to facilitate delivery of medicament from each cannula section (fig 33, via holes 390).
Regarding claim 12, wherein cutting the processed mandrel assembly adjacent both ends of each coil to create a plurality of cannula sections in the process includes providing each cannula section with a length of tubing 400 extending beyond the coil on at least one end of the cannula section (figs 28-32).
Regarding claim 13, wherein forming the cannula with the process includes forming a tapered distal end 400 for the cannula at the length of tubing extending beyond the coil on one end of the cannula section (fig 28).
Regarding claim 14, wherein the process further comprises removing a portion of a spacer from the length of tubing prior to forming the tapered distal end (fig 28, device of Lepulu is indistinguishable from the claimed invention made by such a process).
Regarding claim 15, wherein forming the cannula with the process includes forming one or more infusion holes 390 in a side of the cannula section (fig 33).
Regarding claim 16, wherein each spacer used in the process has a same inner diameter and outer diameter as each of the plurality of coils (fig 28).
Regarding claim 17, wherein each spacer used in the process is comprised of a polymer material (Col.20 ll 43-45).
Regarding claim 18, wherein the process further comprises removing the mandrel prior to cutting the assembly (device of Lepulu is indistinguishable from the claimed invention by such a process).
Regarding claim 19, wherein the process further comprises attaching a barrel 380/382 to a proximal end of each cannula to provide a cannula assembly (fig 22).
Regarding claim 20, wherein the outer tube comprises a polymer (Col.21 ll 10) and the coils comprise a metal (Col.20 ll 3-5 and reference claim 3).
Regarding claim 21, wherein the outer tube 402 defines an inner lumen and wherein the outer tube is formed around the assembly (fig 31) such that each of the plurality of coils is located within the inner lumen of the outer tube (fig 31).
Response to Arguments
Applicant argues on page 5 that the characterization that the cannula of Lepulu is indistinguishable from the claimed cannula is inaccurate.
More specifically, that the cited process in figs 25-33 does not produce a plurality of discrete medicament-delivery cannulas formed from respective cannula sections. Rather, the sections are fused and bonded together to form a an integral tubular structure into a single multi-section cannula, not separate finished cannulas fromed from each cannula section as required by claim 11. The examiner cannot find the claim language that is the basis for the argument. Claim 11 is drawn to “A cannula...”, singular, not plural.
Applicant argues on pages 5 and 6 that the multi-section cannula shown in fig 33 has alternating reinforced and nonreinforced sections and is not the same as the claimed cannula, which results from cutting adjacent both ends of an individual coil to form a discrete cannula section. The examiner is not persuaded, again, the claim is drawn to “A cannula...”, said cannula can be interpreted as Applicant claims, but it can also be interpreted as a singular cannula made of the plurality of cannula sections.
On page 6 Applicant argues the intermediate cut sections cannot be interpreted as the product as they are not configured to facilitate delivery of medicament to a user as required by claim 11. Yet claim 11 is allows for said intermediate sections to be rejoined as part of forming a single cannula. The (single) cannula in claim 11 may be formed of a plurality of cannula sections so long as the cannula is configured to facilitate delivery of medicament from each cannula section (which it is in the final, assembled state).
On page 6, Applicant argues Lepulu’s intermediate sections also lack the structural features of several dependent claims. However, Applicant’s arguments in this section are again based on the (incorrect) argument that the claim (which is drawn to “A cannula...”) requires each cannula section to be a self-contained cannula. The claim allows for the cannula sections to be part of a single, composite device.
Applicant argues on page 7 that Lepulu’s product is structurally different because its reinforcing member is encased in material to form reinforced tubular sections, while claim 11 recites arranging coils on a mandrel, providing spacers on the mandrel between the coils and processing the assembly to form an outer tube around the assembly, the resulting claimed cannula therefore has a coil positioned inside the outer tube, rather than a reinforcing member embedded in the tube wall. Yet the examiner cited Col.21 ll 6-19, which is drawn to layer 402 placed over the tubular body as in fig 29. Thus the cannula has a coil positioned inside the outer tube as claimed.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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