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 § 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) 82-84, 86-89 and 93 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2017/0203033 to Horvath et al. (Horvath hereinafter) in view of U.S. Patent 6,241,710 to VanTassel et al. (VanTassel).
Regarding claim 82, Horvath teaches a transport tube (30) configured to deliver a composition from a source (pump, see paragraph 4) along with a method for its use, the tube comprising a distal passageway (within 30) having a distal tip (321) which is open when initially placed (paragraph 75, absence of occlusion implies openness), a plurality of passages (31, see paragraph 71 re plurality) configured to deliver the composition when the distal tip is occluded (paragraph 74) which, due to the plurality of passages, is configured for use longer than 4 days, and a proximal solid segment (22) configured to reside on a skin surface and in communication with the distal passageway. Horvath teaches a primary infusion path (321) and a secondary path (31) for use when the primary becomes occluded (paragraph 70). Horvath does not teach interconnected passages having the specified dimension. VanTassel teaches a transport tube (2) for delivering a composition, including a distal passageway (hollow center of needle) configured to reside in a subcutaneous space, a closed distal tip (8), a plurality of passages (within 6) with an average diameter which may exceed 40 micrometers (see col. 4, ln. 14-19), and a proximal solid section (4). VanTassel teaches that this structure injects medicament from multiple orifices rather than only delivering a bolus injection. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use the weeping needle structure of VanTassel instead of or in addition to the slit of Horvath in order to provide further infusion capability.
Regarding claim 83, Horvath teaches a plurality of through passages (31, see paragraph 71).
Regarding claim 84, Horvath teaches separated fluid passages (31, i.e. fluid passages which do not interconnect) which are not in fluid communication with each other within the structure of the tube. Additonally, some of the passages taught by VanTassel will be diametrically opposed or otherwise functionally spaced so as to not have fluid communication with each other.
Regarding claim 86, VanTassel teaches that the passages are “open cell”, i.e. interconnected (col. 5, ln. 41-43).
Regarding claims 87-88 and 98, Horvath teaches the use of insulin with the transport tube (see e.g. paragraph 18).
Regarding claim 89, Horvath teaches that a positive pressure builds up when the distal opening is occluded (paragraph 70).
Regarding claim 97, Horvath teaches the limitations of claim 93 from which the claim depends. Horvath teaches replacement of the transport tube (paragraph 6) at a conventional interval of 3 days. Horvath does not specifically state a duration of use of 4 days or longer, but does state that the use of their catheter may have the result that “an infusion site may last longer” (paragraph 87). Taken in combination, Horvath teaches a desired time before replacement of at least three days, and states the motivation of increasing that time to include patient comfort level (paragraph 87). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to replace the apparatus of Horvath after at least 4 days in order to increase patient comfort.
Regarding claim 90, the pressure in the tube relates to the operation of the infusion pump, which is not a part of the claimed invention. As the transport tube of Horvath is capable of being used with such a positive pressure, claim 90 is anticipated.
Claim(s) 85-86 and 91-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath in view of US Pre-Grant Publication 2009/0054866 to Teisen-Simony et al. (Teisen-Simony).
Regarding claims 85, 86 and 91, Horvath teaches the limitations of claim 82 from which this claim depends. Horvath does not teach interconnected passages. VanTassel teaches the passages and their use for infusion, as well as teaching that the size may be larger than 40 microns, as discussed above
Regarding claim 92, as noted above with respect to claim 82, Horvath teaches the limitations of the transport tube save for the porous passages and empty fraction. Horvath also teaches that kinking of tubing is to be avoided (see e.g. paragraph 111). As noted above with respect to claim 86, VanTassel teaches the porous passages.
Claim(s) 93-96 and 98-101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath in view of US Pre-Grant Publication 2009/0325860 to Constantino et al. (Constantino).
Regarding claim 93, Horvath teaches providing the tube, inserting it into subcutaneous space (paragraph 5), delivering a therapeutic amount, and continuing to deliver after occlusion (see e.g. paragraph 70).
Regarding claims 94-96, Horvath as modified in view of VanTassel teaches the limitations of claim 93 as discussed above, but does not specifically teach treatment of the claimed disorders. Constantino teaches another diabetes treatment method, and particularly teaches administration of insulin in the treatment of type 1, type and mellitus types of diabetes (see e.g. paragraph 3). Those of skill in the art will appreciate that such treatment alleviates the symptoms of the disorder for patients so treated. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to treat the claimed conditions with insulin as taught by Horvath and Constantino in order to relieve the symptoms thereof for patients.
Regarding claims 98-99, Horvath teaches the use of insulin, but is silent to the type. Constantino teaches that fast-acting insulins are useful in the treatment of the conditions noted above (see e.g. paragraph 28). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use fast acting insulin as taught by Constantino to provide the noted symptom relief.
Regarding claims 100-101, Horvath teaches the use of insulin, but does not teach the use of excipients. Constantino teaches that excipients may be used to increase dose effectiveness (paragraph 30), including salts. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide excipients as taught by Constantino to the insulin used in the method of Horvath in order to increase dose effectiveness therein.
Regarding claims 100-113, VanTassel teaches a range of pore sizes which overlaps with the claimed ranges (see col. 4, ln. 14-19), rendering them obvious (see MPEP 2144.05). Inasmuch as the numeric ranges are rendered, the functional ranges are presumed to be obvious as well in the absence of evidence or argument regarding distinctions thereof.
Claim(s) 114-115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath in view of VanTassel as applied to claim 82 above and further in view of US Pre-Grant Publication 2005/0079199 to Heruth et al. (Heruth).
Regarding these claims together, Horvath and VanTassel are silent to resin and porogen formation. Heruth teaches porous coatings for drug release, and particularly teaches resins (paragraph 40) and porogens such as sodium bicarbonate (paragraph 44). Heruth teaches that these produce pores of the desired size (paragraph 44) and as such it would have been obvious to use resins and porogens as taught by Heruth before the effective filing date of the invention in order to form the pores of VanTassel in the catheter of Horvath.
Response to Arguments
Applicant’s arguments, see page 8, filed 17 July 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Horvath in view of VanTassel.
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.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 27 September 2026
