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 .
Response to Amendment
The Amendment filed on 2/18/2026 has been entered. Claims 1-7 remain pending in the application.
Applicants amendments to the abstract have overcome the abstract objections previously set forth in the Non-final Office Action mailed 8/18/2025.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 8/18/2025.
Applicants amendments to the claims have failed to overcome all of the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 8/18/2025. Specifically, the rejection of claim 6 under 35 U.S.C. 112 has not been overcome.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to claim 1,
Line 5-6 recites “at least one antimicrobial migration barrier coupled to or integral with only the extravascular proximal portion of the catheter”. There is not support in the original disclosure for this limitation. As shown in the figures, the at least one antimicrobial migration barrier is coupled to the intravascular distal portion indirectly. Since the at least one antimicrobial migration barrier is coupled directly to the extravascular proximal portion of the catheter, and the extravascular proximal portion of the catheter is coupled to the intravascular distal portion, there is not support in the original disclosure to state that “at least one antimicrobial migration barrier coupled to or integral with only the extravascular proximal portion of the catheter”. Appropriate correction is required. Examiner suggests amending claim 1 to state that the at least one antimicrobial migration barrier is directly coupled to only the extravascular proximal portion of the catheter.
Line 8-10 recites “a ledge extending radially from the surface of the catheter configured to block migration of a fibrin sheath along the catheter past the barrier when the catheter is subcutaneously implanted”. There is not support in the original disclosure for this limitation. As shown in figure 3, a fibrin sheath 24 is shown past the barrier. Paragraph [0018] further states “The barrier 34 of FIG. 2 is configured to disrupt the advancement or continuity of the fibrin sheath between the port pocket 20”. Paragraph [0019] further states “the fibrin sheath has a discontinuity at the barrier 34”. Therefore, it appears based on the figures that the barrier can disrupt the continuity of the fibrin sheath, but support does not appear to be present to state “configured to block migration of a fibrin sheath along the catheter past the barrier when the catheter is subcutaneously implanted”. The disclosure is completely silent that the ledge functions to fully block migration of a fibrin sheath along the catheter past the barrier when the catheter is subcutaneously implanted.
In regard to claim 6,
Line 1-3 recites “wherein the at least one antimicrobial migration barrier is configured to elute the antimicrobial agent into an area surrounding the antimicrobial migration barrier”. Claim 6 depends on claim 1. Claim 1 requires the at least one antimicrobial migration barrier to have an outer diameter greater than an outer diameter of the extravascular proximal portion to form a ledge. There is not support in the original disclosure to claim that when the at least one antimicrobial migration barrier forms a ledge as required in claim 1, the at least one antimicrobial migration barrier is also configured to elute the antimicrobial agent into an area surrounding the antimicrobial migration barrier. The disclosure is completely silent regarding that the at least one antimicrobial migration barrier as currently claimed in claim 1 (i.e. forming a ledge) is also being configured to elute the antimicrobial agent into an area surrounding the antimicrobial migration barrier.
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 1-7 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.
In regard to claim 1,
Line 6-7 recites “the antimicrobial migration barrier”. Line 5 of claim 1 recites “at least one antimicrobial migration barrier”. It is unclear if the antimicrobial migration barrier of line 6-7 of claim 1 refers to a specific antimicrobial migration barrier of the at least one antimicrobial migration barrier or if the antimicrobial migration barrier of line 6-7 of claim 1 refers to the at least one antimicrobial migration barrier. For examination purposes Examiner construes “the antimicrobial migration barrier” to be the same as “the at least one antimicrobial migration barrier”. Examiner suggests replacing “the antimicrobial migration barrier” in line 6-7 of claim 1 with “the at least one antimicrobial migration barrier”.
Line 8-9 recites “the surface of the catheter”. There is insufficient antecedent basis for the limitation in this claim. It is unclear if the surface of the catheter refers to the extravascular proximal portion or a surface of the catheter. For examination purposes Examiner construes “the surface of the catheter” to be “a surface of the catheter”. Examiner suggests replacing “the surface of the catheter” in line 8-9 of claim 1 with “a surface of the catheter”.
Line 10 recites “the barrier”. Line 5 of claim 1 recites “at least one antimicrobial migration barrier”. It is unclear if the barrier of line 10 of claim 1 refers to a specific antimicrobial migration barrier of the at least one antimicrobial migration barrier or if the barrier of line 10 of claim 1 refers to the at least one antimicrobial migration barrier. For examination purposes Examiner construes “the barrier” to be the same as “the at least one antimicrobial migration barrier”. Examiner suggests replacing “the barrier” in line 10 of claim 1 with “the at least one antimicrobial migration barrier”.
Examiner notes claims 2-7 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 6,
Line 3 recites “the antimicrobial migration barrier”. Line 1-2 of claim 6 recites “the at least one antimicrobial migration barrier” and claim 1, which claim 6 depends on, recites “at least one antimicrobial migration barrier”. It is unclear if the antimicrobial migration barrier of line 3 of claim 6 refers to a specific antimicrobial migration barrier of the at least one antimicrobial migration barrier or if the antimicrobial migration barrier of line 3 of claim 6 refers to the at least one antimicrobial migration barrier. For examination purposes Examiner construes “the antimicrobial migration barrier” to be the same as “the at least one antimicrobial migration barrier”. Examiner suggests replacing “the antimicrobial migration barrier” in line 3 of claim 6 with “the at least one antimicrobial migration barrier”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (U.S. PG publication 20110009831) further in view of Scherich (U.S. PG publication 20210228781).
In regard to claim 1,
Burkholz discloses an infusion apparatus (see figure 6 and 7, item 10; paragraph [0042]; Examiner notes as supported by paragraph [0042] item 10 can be used for infusion) comprising:
a reservoir (figure 7, item 30);
a catheter (figure 6, item 40) comprising an extravascular proximal portion (see figure 6, item 44; paragraph [0030]; see also figure 7, wherein the portion of item 40 outside of vasculature 22 is construed as the extravascular proximal portion) coupled to the reservoir (see figure 6 and 7) and an intravascular distal portion (figure 6, item 46; see also figure 7, wherein the portion of item 40 inside the vasculature 22 is construed as the intravascular distal portion); and
at least one antimicrobial migration barrier (figure 6 and 7, item 70; paragraph [0036], [0041], and [0047]; wherein the coating 70 prevents the propagation of unwanted organisms) coupled to or integral with only the extravascular proximal portion of the catheter (see figure 6 and 7), wherein the antimicrobial migration barrier comprises an outer diameter greater than an outer diameter of the extravascular proximal portion of the catheter to form a ledge extending radially from the surface of the catheter (see figure 6 and 7) configured to block migration of an organism along the catheter past the barrier when the catheter is subcutaneously implanted (paragraph [0036], [0041], and [0047]).
Burkholz is silent as to the antimicrobial migration barrier configured to block migration of a fibrin sheath along the catheter past the barrier when the catheter is subcutaneously implanted.
Scherich teaches an antimicrobial migration barrier (barrier which contains an anti-thrombogenic and an anti-microbial compound; paragraph [0018], [0036]-[0037]) configured to block migration of a fibrin sheath along the catheter (item 20) past the barrier when the catheter is subcutaneously implanted (paragraph [0007] and [0036]-[0037]; Examiner notes “configured to block migration of a fibrin sheath along the catheter past the barrier when the catheter is subcutaneously implanted” is a functional limitation. The barrier is fully capable of the recited function due to its material properties).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the barrier of Burkholz which forms a ledge and which contains an anti-microbial to additionally include an anti-thrombogenic, as taught by Scherich, therefore resulting in a ledge extending radially from the surface of the catheter configured to block migration of a fibrin sheath along the catheter past the barrier when the catheter is subcutaneously implanted, for the purpose of limiting formation of a fibrin sheath to enable unimpaired infusion (paragraph [0005] and [0007] of Scherich).
In regard to claim 2,
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Burkholz in view of Scherich teaches the infusion apparatus of claim 1, comprising a needle access port (see figure 7 above of Burkholz and figure 6 of Burkholz wherein needle 60 is shown; see also figure 1 of Burkholz and paragraph [0029] of Burkholz which supports a needle 60 with hub 50 can be received within the reservoir) associated with the reservoir (see figure 7 above of Burkholz).
In regard to claim 4,
Burkholz in view of Scherich teaches the infusion apparatus of claim 1, wherein the at least one antimicrobial migration barrier is configured to inhibit both proximal and distal migration of microbes along the catheter (paragraph [0041] and [0047] of Burkholz).
In regard to claim 5,
Burkholz in view of Scherich teaches the infusion apparatus of claim 4, wherein the at least one antimicrobial migration barrier comprises an antimicrobial agent (paragraph [0047] of Burkholz).
In regard to claim 7,
Burkholz in view of Scherich teaches the infusion apparatus of claim 1, wherein the reservoir is detachable from the catheter (see figure 6 and 7 of Burkholz wherein the reservoir is detachable from the catheter at least by removing or breaking the catheter from the reservoir. Claim 7 does not specify how the reservoir is detachable from the catheter).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (U.S. PG publication 20110009831) in view of Scherich (U.S. PG publication 20210228781) as applied to claim 1, and further in view of Blackman (U.S. PG publication 20190184134).
In regard to claim 3,
Burkholz in view of Scherich teaches the infusion apparatus of claim 1.
Burkholz in view of Scherich is silent as to wherein the catheter comprises more than one lumen.
Blackman teaches wherein the catheter (figure 1D, item 102) comprises more than one lumen (see figure 1D wherein the catheter 102 can comprise more than one lumen 103).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz in view of Scherich to include wherein the catheter comprises more than one lumen and to modify the reservoir accordingly, as taught by Blackman, for the purpose of enabling the delivery of two materials that can be kept separate during the delivery (paragraph [0030] of Blackman).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (U.S. PG publication 20110009831) in view of Scherich (U.S. PG publication 20210228781) as applied to claim 5, and further in view of Wiley (U.S. PG publication 20110118677).
In regard to claim 6,
Burkholz in view of Scherich teaches the infusion apparatus of claim 5.
Burkholz in view of Scherich is silent as to wherein the at least one antimicrobial migration barrier is configured to elute the antimicrobial agent into an area surrounding the antimicrobial migration barrier.
Wiley teaches wherein the at least one antimicrobial migration barrier (antimicrobial coating on cover 16) is configured to elute the antimicrobial agent into an area surrounding the antimicrobial migration barrier (paragraph [0032]).
Further, Wiley teaches that an antimicrobial barrier that is silver or an antimicrobial configured to elute from the cover at a desired rate in order to provide desired properties to the surface of the outer cover (paragraph [0032]) could all be used to achieve the same result (paragraph [0032]) and thus silver or an antimicrobial configured to elute from the cover at a desired rate were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute an antimicrobial agent configured to elute at a desired rate in place of the antimicrobial agent of Burkholz in view of Scherich therefore resulting in wherein the at least one antimicrobial migration barrier is configured to elute the antimicrobial agent into an area surrounding the antimicrobial migration barrier since it has been held that substituting parts of an invention involves only routine skill in the art and for the purpose of providing desired properties (paragraph [0032] of Wiley). Paragraph [0053] of Burkholz additionally supports modifications can be made.
Response to Arguments
Applicant's arguments filed 2/18/2026 in regard to the rejections under 35 U.S.C. 112 have been fully considered but they are not persuasive. Applicant argues the claims have been amended in accordance with the Examiner’s recommendations. In claim 6, line 3 “the antimicrobial migration barrier” was not amended as recommended by the Examiner and no other arguments have been provided. Accordingly, the rejection of claim 6 under 35 U.S.C. 112(b) remains.
Applicant’s arguments with respect to claims 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785