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 Objections
Claims 84, 86 are objected to because of the following informalities: the phrase “a through-passage” (or “an interconnected passage”) does not match with “in fluid communication with one another”. Appropriate correction is required.
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 87-88 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 these claims together, the claims recite details of the composition. However, the parent claim relates to a “transport tube” rather than a fluid composition. It is therefore unclear whether the claimed invention includes the recited substances. For the purposes of this office action, the examiner will interpret the composition limitations as a functional limitation.
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) 82-84, 87-89 and 93 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2017/0203033 to Horvath et al. (Horvath hereinafter).
Regarding claims 82 and 93, 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.
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.
Regarding claims 87-88 and 98, as best understood by the examiner, the particular compound infused by the transport tube does not bear on the structure of the claimed invention. Nonetheless, 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 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 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) 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath.
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.
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. Teisen-Simony teaches that an insulin infusion apparatus may use a porous portion of a needle to allow preservatives to diffuse from the cannula and into the bloodstream for a bactericidal effect (paragraph 118). Such porous materials are known to have interconnection of passages therein due to the porous structure. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a porous material as taught by Teisen-Simony in order to allow for a bactericidal effect from preservatives in the infused insulin.
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 claims 85, 86, and 91, Teisen-Simony teaches the use of porous passages. Teisen-Simony further teaches that the porosity may be widely adjusted by the use of various manufacturing techniques and materials (paragraph 119). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to select a porosity for the transport tube of Horvath having a sufficiently low empty fraction to prevent kinking using the techniques taught by Teisen-Simony.
Claim(s) 94-96 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 claims 94-96, Horvath 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.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 13 December 2025