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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-15) in the reply filed on 1/15/26 is acknowledged. The traversal is on the ground(s) that there not undue search burden across the claim groups. This is not found persuasive because of the reasons for search burden set forth in the prior action, which are not particularly countered by the traversal. Examiner acknowledges that the possibility for rejoinder will be considered, as appropriate, upon allowance of elected claims. Claims 16-20 are therefore withdrawn from consideration.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 8, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 5 and 14, the claims appear to attempt to positively recite a method step within the product claim, and it is thus unclear how to interpret claims 5 and 14 as written. For the purposes of examination, the claims will be interpreted as reciting a functional limitation of the claimed inner conduit (claim 5) and structural supports (claim 14). Claim 8 depends from claim 5 and inherits this deficiency.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5, 7, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (US 20150126971) in view of Shikani et al. (US 5762638).
Regarding claim 1 and 7, Muller et al. discloses a catheter (see at least fig. 2) comprising: an outer conduit 12 that comprises a first polymer (par. 0019); an inner conduit 11 that comprises a second polymer (par. 0019); a structural support 13 intermittently disposed in a region between the outer conduit and the inner conduit (see fig. 2); where the structural support contacts the inner conduit and the outer conduit (see fig. 2); except for disclosing the structural support comprises a first biological agent that is released to a region outside the catheter via the outer conduit, the agent being dexamethasone. However, Shikani et al. teaches providing a biological agent in a structural support to be delivered to a region outside the catheter via the conduit (support in the form of polymer coating 11/12, fig. 9c; col. 6, ln. 3-8; col. 7, ln. 6-15; col. 12, ln. 4-7, 44-47), the agent being dexamethasone (col. 6, ln. 11-14). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Muller et al. device to utilize biological agents in the structural supports, as taught by Shikani et al., for the purpose of providing sufficient structure for the delivery of beneficial agents in combination with normal operation of the catheter (abstract).
Regarding claims 5 and 8, as best understood, the inner conduit of Muller et al. is fully capable of transporting a second biological agent from a pump to a body of a living being, wherein the second biological agent is insulin (see fig. 2)
Regarding claim 10, Muller et al. discloses the structural support comprises the same polymer as the outer conduit (par. 0019).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. in view of Shikani et al., and further in view of Ichikawa et al. (US 6827798).
Regarding claim 2, Muller et al. in view of Shikani et al. fails to teach the first polymer is different from the second polymer, the first polymer is an amorphous elastomer and where the second polymer is a semi-crystalline polymer, and/or the first polymer is polydimethylsiloxane and where the second polymer is a polyolefin. However, Ichikawa et al. teaches providing different polymers, including the combinations claimed, for different structural elements of a catheter to impart desired properties (col. 9, ln. 29-32; col. 10, ln. 62 – col. 11, ln. 7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Muller et al. in view of Shikani et al. to utilize different polymers for the first and second polymers, including the combinations claimed, as taught by Ichikawa et al., for the purpose of achieving desired material properties of each catheter element.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. in view of Shikani et al., and further in view of Currier et al. (US 20040015138).
Regarding claim 6, Muller et al. in view of Shikani et al. fails to specifically disclose a conical conduit in contact with the outer conduit and the inner conduit at a distal end of the catheter; where the conical conduit is operative to discharge a second biological agent into a body of a living being. However, Currier et al. teaches providing a conical conduit 22 at a distal end of a multi-lumen catheter 20 (fig. 1A) which is operative to discharge a “second” biological agent into the body (via connection between lumen 28 of the conical conduit and lumen 26 of the catheter, the second agent being an agent capable of being delivered through these lumens; lumen 26 of Currier et al. corresponding to the inner lumen of conduit 11 in Muller et al.). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muller et al. in view of Shikani et al. to utilize a distal conical conduit as claimed, as taught by Currier et al., for the purpose of providing sufficient structure to ease advancement of the catheter while allowing delivery through the central lumen of the catheter.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. in view of Shikani et al., and further in view of Altman et al. (US 20120016311).
Regarding claim 9, Muller et al. in view of Shikani et al. fails to specifically teach the first biological agent is blended with a channeling agent. However, Altman et al. teaches delivery of blended biological/channeling agents (par. 0088). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Muller et al. in view of Shikani et al. to utilize a biological agent blended with a channeling agent, as taught by Altman et al., for the purpose of providing the additional benefits of the channeling agent.
Claim(s) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. in view of Shikani et al., and further in view of Turjman (US 20190167945).
Regarding claims 11-15, (claim 14 as best understood), Muller et al. discloses a plurality of periodically arranged structural supports in the form of consecutive turns of the spiral structure 13, but fails to specifically disclose perdiodically and/or aperiodically spaced structural supports which do not substantially change a flexibility of the catheter as claimed, or the structural support is a foam. However, Turjman teaches utilizing a periodically spaced series of structural supports in the form of micro-pillars 700 (fig. 7; par. 0055, 0061-0063) which do not substantially change flexibility from the desired properties for the catheter (par. 0004) which can comprise foam (par. 0055). Turjman also teaches alternatively using aperiodically spaced supports (claim 9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the structural support of Muller et al. to be the periodic spaced supports and/or foam of Turjman, since Turjman teaches such an arrangement will maintain patency of the lumen while allowing fluid flow therethrough (par. 0061-0063), and further since the modification is the result of simple substitution of one known element (shaped support of Turjman) for another (shaped support of Muller et al.) to achieve a predictable result (maintaining lumen patency, flow therethrough, and desired catheter properties).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached notice of references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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